LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113


Device Classification Name

antinuclear antibody, antigen, control

510(k) Number K024232
Device Name LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact yvette lloyd
Regulation Number 866.5100
Classification Product Code
LKJ  
Date Received 12/23/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No