MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS


Device Classification Name

immunoassay method, troponin subunit

510(k) Number K024193
Device Name MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
Original Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Original Contact ann m quinn
Regulation Number 862.1215
Classification Product Code
MMI  
Subsequent Product Code
JIS  
Date Received 12/20/2002
Decision Date 02/21/2003
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