510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GKAClass II

Abnormal Hemoglobin Quantitation

21 CFR 864.7415 / Hematology
FDA source (opens on fda.gov)

GKA is the FDA product code for Abnormal Hemoglobin Quantitation, a class II device type, regulated under 21 CFR 864.7415. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
GKA
Device name
Abnormal Hemoglobin Quantitation
Regulation
21 CFR 864.7415
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
10

Clearances, product code GKA

By decision year
23 clearances under product code GKA with a decision year between 1981 and 2024, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GKA by decision year
YearClearances
19811
19822
19842
19931
19951
19962
20041
20051
20062
20081
20091
20101
20122
20171
20181
20221
20231
20241

Applicants with the most clearances

Product code GKA
Applicants holding the most 510(k) clearances under product code GKA
ApplicantClearances
Sebia, Inc.5
Bio-Rad3
Helena Laboratories, Corp.3
Bio-Rad Laboratories Inc.2
Trinity Biotech (Primus Corporation dba Trinity Biotech)2
Beckman Instruments, Inc.1
Bio-Rad Laboratories Inc., Clinical Systems Divisi1
Interlab S.r.l.1
Isolab, Inc.1
Ortho Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code