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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Salmonella Spp.
510(k) Number K910438
Device Name DIPSTICK SALMONELLA
Applicant
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Applicant Contact RAYMOND L MILLER
Correspondent
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Correspondent Contact RAYMOND L MILLER
Regulation Number866.3550
Classification Product Code
GRM  
Date Received01/31/1991
Decision Date 09/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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