PH AND AMINES EXTERNAL CONTROL SET


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K022851
Device Name PH AND AMINES EXTERNAL CONTROL SET
Original Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Original Contact robin weiner
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 08/27/2002
Decision Date 09/27/2002
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