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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Immunoreactive Insulin
510(k) Number K963911
Device Name ALPCO/MERCODIA INSULIN ELISA
Applicant
American Laboratory Products Co., Ltd.
87 Indian Rock Rd.
Windham,  NH  03087
Applicant Contact RICHARD CONLEY
Correspondent
American Laboratory Products Co., Ltd.
87 Indian Rock Rd.
Windham,  NH  03087
Correspondent Contact RICHARD CONLEY
Regulation Number862.1405
Classification Product Code
CFP  
Date Received09/30/1996
Decision Date 11/01/1996
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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