Product code JWW— Microbiology

BLASTOMYCES DERMATITIDIS, ANTIGEN

Classification name: Antigen, Cf, B. Dermatitidis
Device class: Class 2
Regulation: 21 CFR 866.3060
Advisory panel: Microbiology
Total cleared: 3
First cleared: 1980-01-17
Most recent: 1980-09-26

Market context for product code JWW

FDA has cleared 3 devices under product code JWW, all in 1980, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code JWW

Meridian Diagnostics, Inc.2 clearances
Nolan Biological Laboratories, Inc.1 clearance

Recent clearances under product code JWW

K802128 — IMMUNODIFFUSSION REAGENTS/SEROLOGICALNolan Biological Laboratories, Inc.·1980-09-26
K792683 — BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSIONMeridian Diagnostics, Inc.·1980-01-23
K792680 — BLASTOMYCES DERMATITIDIS, ANTIGENMeridian Diagnostics, Inc.·1980-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.