LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131


Device Classification Name

antinuclear antibody, indirect immunofluorescent, antigen, control

510(k) Number K024230
Device Name LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact yvette lloyd
Regulation Number 866.5100
Classification Product Code
DHN  
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