HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103


Device Classification Name

bilirubin (total and unbound) in the neonate test system

510(k) Number K021622
Device Name HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
Original Applicant
HILL-ROM AIR-SHIELDS
330 jacksonville rd.
hatboro, 
PA 
19040

Original Contact monica ferrante
Regulation Number 862.1113
Classification Product Code
MQM  
Date Received 05/16/2002
Decision Date 04/01/2003
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