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

Plasma, Coagulation Factor Deficient

21 CFR 864.7290 / Hematology
FDA source (opens on fda.gov)

GJT is the FDA product code for Plasma, Coagulation Factor Deficient, a class II device type, regulated under 21 CFR 864.7290. As of , FDA records hold 79 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GJT
Device name
Plasma, Coagulation Factor Deficient
Regulation
21 CFR 864.7290
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
79
Ingested recalls
3

Clearances, product code GJT

By decision year
79 clearances under product code GJT with a decision year between 1988 and 2023, 1990 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code GJT by decision year
YearClearances
19886
19899
199011
19911
19922
19938
19946
19955
19962
19979
19981
19995
20035
20042
20052
20113
20181
20231

Applicants with the most clearances

Product code GJT
Applicants holding the most 510(k) clearances under product code GJT
ApplicantClearances
Instrumentation Laboratory Co.10
Medical Diagnostic Technologies, Inc.10
American Bioproducts Co.9
Sigma Chemical Co.8
Precision Biologicals, Inc.7
Biomerieux Vitek, Inc.5
Ortho Diagnostic Systems, Inc.5
Sigma Diagnostics, Inc.4
Behring Diagnostics, Inc.3
Precision BioLogic Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code