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

Antigen, Positive Control, Cryptococcus Neoformans

21 CFR 866.3165 / Microbiology
FDA source (opens on fda.gov)

JWK is the FDA product code for Antigen, Positive Control, Cryptococcus Neoformans, a class II device type, regulated under 21 CFR 866.3165. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JWK
Device name
Antigen, Positive Control, Cryptococcus Neoformans
Regulation
21 CFR 866.3165
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
1
Ingested recalls
0

Clearances, product code JWK

By decision year
1 clearance under product code JWK with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JWK by decision year
YearClearances
19801

Applicants with the most clearances

Product code JWK
Applicants holding the most 510(k) clearances under product code JWK
ApplicantClearances
Meridian Diagnostics, 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 JWK.