LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K992172
Device Name LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Applicant Contact elizabeth platt
Correspondent
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Correspodent Contact elizabeth platt
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 06/28/1999
Decision Date 09/02/1999
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