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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Progesterone
510(k) Number K955769
Device Name ACCESS PROGESTERONE ASSAY
Applicant
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Applicant Contact DENNIS S GRIFFIN
Correspondent
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA,  MN  55318 -1084
Correspondent Contact DENNIS S GRIFFIN
Regulation Number862.1620
Classification Product Code
JLS  
Subsequent Product Code
JIS  
Date Received12/21/1995
Decision Date 02/05/1996
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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