ELECSYS THYROGLOBULIN CALCHECK


information about

Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K001015
Device Name ELECSYS THYROGLOBULIN CALCHECK
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50457
indianapolis, 
IN 
46250 -0457

Original Contact kay a taylor
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 03/29/2000
Decision Date 04/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No