IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5


Device Classification Name

fluorometric method, cpk or isoenzymes

510(k) Number K991797
Device Name IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Applicant Contact edward m levine
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Correspodent Contact edward m levine
Regulation Number 862.1215
Classification Product Code
JHX  
Date Received 05/26/1999
Decision Date 06/09/1999
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