LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115


Device Classification Name

anti-sm antibody, antigen and control

510(k) Number K024219
Device Name LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact yvette lloyd
Regulation Number 866.5100
Classification Product Code
LKP  
Date Received 12/23/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No