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

Antigen, Cf, B. Dermatitidis

21 CFR 866.3060 / Microbiology
FDA source (opens on fda.gov)

JWW is the FDA product code for Antigen, Cf, B. Dermatitidis, a class II device type, regulated under 21 CFR 866.3060. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JWW
Device name
Antigen, Cf, B. Dermatitidis
Regulation
21 CFR 866.3060
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code JWW

By decision year
3 clearances under product code JWW with a decision year between 1980 and 1980, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JWW by decision year
YearClearances
19803

Applicants with the most clearances

Product code JWW
Applicants holding the most 510(k) clearances under product code JWW
ApplicantClearances
Meridian Diagnostics, Inc.2
Nolan Biological Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JWW.