VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS


Device Classification Name

calibrator, primary

510(k) Number K022901
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
Original Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek dr.
rochester, 
NY 
14626 -5101

Original Contact marlene hanna
Regulation Number 862.1150
Classification Product Code
JIS  
Date Received 09/03/2002
Decision Date 09/27/2002
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