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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K924860
Device Name AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
Applicant
Tosoh Medics, Inc.
800 A Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact RICHARD M CROMPTON
Correspondent
Tosoh Medics, Inc.
800 A Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact RICHARD M CROMPTON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/28/1992
Decision Date 03/04/1993
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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