PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794


Device Classification Name

antigen, galactomannan, aspergillus spp.

510(k) Number K023857
Device Name PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
Original Applicant
BIO-RAD
clinical diagnostics group
6565 185th avenue ne
redmond, 
WA 
98052

Original Contact christopher bentsen
Regulation Number 866.3040
Classification Product Code
NOM  
Date Received 11/20/2002
Decision Date 05/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls