CDTOX A OIA


Device Classification Name

reagents, clostridium difficile toxin

510(k) Number K991829
Device Name CDTOX A OIA
Applicant
BIOSTAR, INC.
6655 lookout rd.
boulder, 
CO 
80301

Applicant Contact roger c briden
Correspondent
BIOSTAR, INC.
6655 lookout rd.
boulder, 
CO 
80301

Correspodent Contact roger c briden
Regulation Number 866.2660
Classification Product Code
LLH  
Date Received 05/28/1999
Decision Date 11/02/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No