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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, time, prothrombin
510(k) Number K922565
Device Name NEOPLASTINE(R) CI KIT
Applicant
AMERICAN BIOPRODUCTS CO.
601 NORTH JEFFERSON RD.
PARSIPPANY,  NJ  07054
Applicant Contact LOC B LE
Correspondent
AMERICAN BIOPRODUCTS CO.
601 NORTH JEFFERSON RD.
PARSIPPANY,  NJ  07054
Correspondent Contact LOC B LE
Regulation Number864.7750
Classification Product Code
GJS  
Date Received06/01/1992
Decision Date 12/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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