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

Instrument, Coagulation, Automated

21 CFR 864.5400 / Hematology
FDA source (opens on fda.gov)

GKP is the FDA product code for Instrument, Coagulation, Automated, a class II device type, regulated under 21 CFR 864.5400. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and 31 recalls.

Classification record

Product code
GKP
Device name
Instrument, Coagulation, Automated
Regulation
21 CFR 864.5400
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
49
Ingested recalls
31

Clearances, product code GKP

By decision year
49 clearances under product code GKP with a decision year between 1982 and 2024, 1999 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GKP by decision year
YearClearances
19821
19881
19894
19904
19923
19934
19941
19954
19964
19972
19981
19996
20003
20022
20031
20041
20071
20081
20091
20151
20161
20231
20241

Applicants with the most clearances

Product code GKP
Applicants holding the most 510(k) clearances under product code GKP
ApplicantClearances
Siemens Healthcare Diagnostics Inc.9
Instrumentation Laboratory Co.9
Helena Laboratories, Corp.5
Medical Laboratory Automation Systems, Inc.5
American Bioproducts Co.3
Haemoscope Corp.3
bioMerieux, Inc.3
Bio/Data Corp.2
Ortho Diagnostic Systems, Inc.2
Biomerieux Vitek, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order