LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST


Device Classification Name

immunoassay method, troponin subunit

510(k) Number K022946
Device Name LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
Original Applicant
PRINCETON BIOMEDITECH CORP.
4242 u.s. rt. 1
monmouth junction, 
NJ 
08852 -1905

Original Contact jemo kang
Regulation Number 862.1215
Classification Product Code
MMI  
Date Received 09/04/2002
Decision Date 10/08/2002
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