Home›USA›UTAK LABORATORIES, INC.

UTAK LABORATORIES, INC.

USA · Valencia

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Australia — 4 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

3listed device types

Class I 3Class II 0Class III 0

plus 24 registration records and 23 510(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

13active device licences

Class II 13

21 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 2 5

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 States24 registration records, 23 510(k), 0 PMA, 1 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: UTAK LABORATORIES, INC. · UTAK LABORATORIES INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K903061	UTAK LABORATORIES TOXICOLOGY CONTROL	1991-04-12
US	K883147	TRACE ELEMENTS SERUM TOXICOLOGY CONTROL	1988-10-06
US	K862419	SERUM VANCOMYCIN TOXICOLOGY CONTROL	1986-11-13
CA	94161	LYOPHILIZED SERUM TRACE ELEMENTS	Class II
CA	94175	LYOPHILIZED URINE DRUGS OF ABUSE	Class II
CA	94176	LYOPHILIZED URINE THERAPEUTIC DRUG MONITORING	Class II

UTAK LABORATORIES, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies