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

Device, Bleeding Time

21 CFR 864.6100 / Hematology
FDA source (opens on fda.gov)

JCA is the FDA product code for Device, Bleeding Time, a class II device type, regulated under 21 CFR 864.6100. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JCA
Device name
Device, Bleeding Time
Regulation
21 CFR 864.6100
Device class
Class II
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
7
Ingested recalls
1

Clearances, product code JCA

By decision year
7 clearances under product code JCA with a decision year between 1977 and 1991, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JCA by decision year
YearClearances
19771
19801
19831
19851
19871
19912

Applicants with the most clearances

Product code JCA
Applicants holding the most 510(k) clearances under product code JCA
ApplicantClearances
Accriva Diagnostics, Inc.2
American Dade1
General Diagnostics1
Helena Laboratories, Corp.1
bioMerieux, Inc.1
Ulster Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code