GKA

Abnormal Hemoglobin Quantitation

Product code: GKA
Device name: Abnormal Hemoglobin Quantitation
Device class: Class 2
21 CFR: 21 CFR 864.7415
Medical specialty: Hematology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 23 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-04.

Number	Decision date	Applicant	Device name	Summary
K232027	2024-04-04	Sebia	CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument	PDF

1 summaries are archived here for direct download.

Official FDA classification page: GKA

Classification and pathway per current FDA publications. Data from openFDA (CC0).