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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K955266
Device Name ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
Applicant
Boehringer Mannheim Italia Spa
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Applicant Contact CLEVE W LAIR
Correspondent
Boehringer Mannheim Italia Spa
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Correspondent Contact CLEVE W LAIR
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/15/1995
Decision Date 02/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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