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

Bothrops Atrox Reagent

21 CFR 864.8100 / Hematology
FDA source (opens on fda.gov)

JCO is the FDA product code for Bothrops Atrox Reagent, a class II device type, regulated under 21 CFR 864.8100. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JCO
Device name
Bothrops Atrox Reagent
Regulation
21 CFR 864.8100
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
7
Ingested recalls
0

Clearances, product code JCO

By decision year
7 clearances under product code JCO with a decision year between 1978 and 1996, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JCO by decision year
YearClearances
19781
19842
19851
19891
19931
19961

Applicants with the most clearances

Product code JCO
Applicants holding the most 510(k) clearances under product code JCO
ApplicantClearances
Medical Diagnostic Technologies, Inc.2
Behring Diagnostics, Inc.1
Bio/Data Corp.1
E.I. Dupont de Nemours & Co., Inc.1
Sigma Chemical Co.1
Wellcome Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code