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

Activated Whole Blood Clotting Time

21 CFR 864.7140 / Hematology
FDA source (opens on fda.gov)

JBP is the FDA product code for Activated Whole Blood Clotting Time, a class II device type, regulated under 21 CFR 864.7140. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
JBP
Device name
Activated Whole Blood Clotting Time
Regulation
21 CFR 864.7140
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
24
Ingested recalls
10

Clearances, product code JBP

By decision year
24 clearances under product code JBP with a decision year between 1979 and 2023, 2000 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JBP by decision year
YearClearances
19791
19831
19841
19862
19901
19911
19921
19941
19961
19972
19981
19991
20004
20022
20032
20071
20231

Applicants with the most clearances

Product code JBP
Applicants holding the most 510(k) clearances under product code JBP
ApplicantClearances
Accriva Diagnostics, Inc.4
Sienco, Inc.4
Array Medical, Inc.2
Helena Laboratories, Corp.2
Hemotec, Inc.2
I-Stat Corp.2
B & D Corp.1
Cardiovascular Diagnostics, Inc.1
Future Impex Corp.1
Haemoscope Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code