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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, folic, radioimmunoassay
510(k) Number K922823
Device Name ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
Applicant
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact JAN OLSEN
Correspondent
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact JAN OLSEN
Regulation Number862.1295
Classification Product Code
CGN  
Date Received06/11/1992
Decision Date 08/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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