CIDEX OPA SOLUTION TEST STRIP


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K992341
Device Name CIDEX OPA SOLUTION TEST STRIP
Applicant
SERIM RESEARCH CORP.
23565 reedy dr.
elkhart, 
IN 
46514

Applicant Contact james e christner
Correspondent
SERIM RESEARCH CORP.
23565 reedy dr.
elkhart, 
IN 
46514

Correspodent Contact james e christner
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 07/13/1999
Decision Date 11/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized