IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER


Device Classification Name

radioimmunoassay, parathyroid hormone

510(k) Number K022603
Device Name IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Original Contact edward m levine
Regulation Number 862.1545
Classification Product Code
CEW  
Subsequent Product Codes
CDD   CDP   CDZ   CEC   CEE  
CEP   CFL   CFP   CFT   CGI   CGJ  
CGN   CGR   CGT   CHP   CKG   DCN  
DDR   DFJ   DGO   DHA   DHB   DHX  
DIO   DIP   DKZ   JFH   JHR   JHX  
JJE   JKC   JKD   JLS   JMF   JMG  
JMM   JZG   JZO   KLI   KLS   KLT  
KXT   LAF   LDJ   LEG   LFM   LFX  
LFZ   LGC   LGD   LOJ   LPS   LTJ  
LTK   LYR   MMI   MOI   MSW  
Date Received 08/06/2002
Decision Date 08/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Toxicology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls