ACON STREP A TWIST TEST DEVICE


Device Classification Name

antigens, all groups, streptococcus spp.

510(k) Number K023766
Device Name ACON STREP A TWIST TEST DEVICE
Original Applicant
ACON LABORATORIES CO.
4108 sorrento valley blvd.
san diego, 
CA 
92121

Original Contact edward tung
Regulation Number 866.3740
Classification Product Code
GTY  
Date Received 11/12/2002
Decision Date 02/10/2003
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