SERIM DISINTEK OPA TEST STRIP


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K081370
Device Name SERIM DISINTEK OPA TEST STRIP
Applicant
SERIM RESEARCH CORP.
3506 reedy st.
elkhart, 
IN 
46561

Applicant Contact patricia rupchock
Correspondent
SERIM RESEARCH CORP.
3506 reedy st.
elkhart, 
IN 
46561

Correspodent Contact patricia rupchock
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 05/15/2008
Decision Date 07/11/2008
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