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

Antithrombin Iii Quantitation

21 CFR 864.7060 / Hematology
FDA source (opens on fda.gov)

JBQ is the FDA product code for Antithrombin Iii Quantitation, a class II device type, regulated under 21 CFR 864.7060. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JBQ
Device name
Antithrombin Iii Quantitation
Regulation
21 CFR 864.7060
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
56
Ingested recalls
0

Clearances, product code JBQ

By decision year
56 clearances under product code JBQ with a decision year between 1977 and 2025, 1978 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JBQ by decision year
YearClearances
19773
19785
19792
19801
19814
19834
19841
19851
19861
19884
19891
19904
19911
19922
19944
19952
19962
19972
19981
20002
20022
20031
20041
20051
20061
20071
20091
20251

Applicants with the most clearances

Product code JBQ
Applicants holding the most 510(k) clearances under product code JBQ
ApplicantClearances
Instrumentation Laboratory Co.9
American Bioproducts Co.2
Beckman Instruments, Inc.2
Behring Diagnostics, Inc.2
E.I. Dupont de Nemours & Co., Inc.2
Helena Laboratories, Corp.2
Ortho Diagnostics, Inc.2
Pharmaseal Div., Baxter Healthcare Corp.2
Sigma Diagnostics, Inc.2
Abbott Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code