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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K870042
Device Name ASSERA-PLATE PROTEIN S KIT
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact LOC B LE,PHD
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact LOC B LE,PHD
Date Received01/05/1987
Decision Date 02/13/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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