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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 K922040
Device Name NEOPLASTINE CI PLUS
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 Received05/01/1992
Decision Date 06/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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