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American Laboratory Products Co., Ltd.

USA · Salem

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

38listed device types

Class I 22Class II 16Class III 0

plus 40 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States40 registration records, 27 510(k), 0 PMA, 186 excluded

Brazil0 confirmed, 20 excluded

Canada0 confirmed, 13 excluded

Manufacturer names merged into this page: American Laboratory Products Company

FDA 510(k) clearances by year

11991

11994

71995

111996

21997

21998

22001

12002

FDA listed device types

showing 8 of 38

Radioimmunoassay, Prolactin (Lactogen) 1Radioimmunoassay, Estriol 1Radioimmunoassay, 17-Hydroxyprogesterone 1Radioimmunoassay, Immunoreactive Insulin 1Radioimmunoassay, Glucagon 1Radioimmunoassay, Androstenedione 1Radioimmunoassay, C-Peptides Of Proinsulin 1Radioimmunoassay, Luteinizing Hormone 1

Market	Identifier	Name	Class / date
US	K012576	CIC-C1Q EIA	2002-01-29
US	K011415	ALPCO MILENIA ANTI-TG EIA	2001-05-30
US	K011201	ALPCO MILENIA ANTI-TPO ELISA	2001-05-24

American Laboratory Products Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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