ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650


Device Classification Name

acid phosphatase, naphthyl phosphate

510(k) Number K023840
Device Name ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact andres holle
Regulation Number 862.1020
Classification Product Code
CKB  
Subsequent Product Codes
JIX   JJY  
Date Received 11/18/2002
Decision Date 01/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No