LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K022041
Device Name LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
Original Applicant
BIO-RAD LABORATORIES, INC.
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact maria zeballos
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 06/24/2002
Decision Date 07/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No