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

System, Fibrinogen Determination

21 CFR 864.7340 / Hematology
FDA source (opens on fda.gov)

KQJ is the FDA product code for System, Fibrinogen Determination, a class II device type, regulated under 21 CFR 864.7340. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KQJ
Device name
System, Fibrinogen Determination
Regulation
21 CFR 864.7340
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
28
Ingested recalls
3

Clearances, product code KQJ

By decision year
28 clearances under product code KQJ with a decision year between 1980 and 2025, 1981 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KQJ by decision year
YearClearances
19803
19815
19844
19881
19891
19902
19922
19933
19941
19973
20051
20071
20251

Applicants with the most clearances

Product code KQJ
Applicants holding the most 510(k) clearances under product code KQJ
ApplicantClearances
Behring Diagnostics, Inc.2
Bio/Data Corp.2
Diatech, Inc.2
Instrumentation Laboratory Co.2
American Dade1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Crestat Diagnostics, Inc.1
Siemens Healthcare Diagnostics Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Helena Laboratories, Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code