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

Test, Thromboplastin Generation

21 CFR 864.7900 / Hematology
FDA source (opens on fda.gov)

GKQ is the FDA product code for Test, Thromboplastin Generation, a class I device type, regulated under 21 CFR 864.7900. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GKQ
Device name
Test, Thromboplastin Generation
Regulation
21 CFR 864.7900
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code GKQ

By decision year
1 clearance under product code GKQ with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GKQ by decision year
YearClearances
19821

Applicants with the most clearances

Product code GKQ
Applicants holding the most 510(k) clearances under product code GKQ
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1

Companies listing this code with FDA

Companies whose registered establishments list this code