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510(k) K893884

BACTON TM, BASIC TM, APO B REAGENT by Catachem, Inc. — Product Code MSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1989
Date Received
May 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apolipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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