PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422


Device Classification Name

test, time, prothrombin

510(k) Number K021190
Device Name PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact jennifer tribbett
Regulation Number 864.7750
Classification Product Code
GJS  
Date Received 04/15/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls