IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)


Device Classification Name

fluorometric method, cpk or isoenzymes

510(k) Number K022118
Device Name IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Original Contact edward m levine
Regulation Number 862.1215
Classification Product Code
JHX  
Date Received 07/01/2002
Decision Date 07/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls