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

Test, Thrombin Time

21 CFR 864.7875 / Hematology
FDA source (opens on fda.gov)

GJA is the FDA product code for Test, Thrombin Time, a class II device type, regulated under 21 CFR 864.7875. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
GJA
Device name
Test, Thrombin Time
Regulation
21 CFR 864.7875
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
20
Ingested recalls
4

Clearances, product code GJA

By decision year
20 clearances under product code GJA with a decision year between 1979 and 2005, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GJA by decision year
YearClearances
19791
19802
19811
19821
19842
19851
19861
19882
19891
19901
19922
19931
19941
19971
19981
20051

Applicants with the most clearances

Product code GJA
Applicants holding the most 510(k) clearances under product code GJA
ApplicantClearances
Bio/Data Corp.3
General Diagnostics3
American Bioproducts Co.2
Behring Diagnostics, Inc.2
American Dade1
Biomerieux Vitek, Inc.1
Haemachem, Inc.1
Helena Laboratories, Corp.1
Instrumentation Laboratory Co.1
Accriva Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code