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510(k) K921862

BACTON(TM), AUTO-APO B REAGENT by Bacton Assay Systems, Inc. — Product Code MSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1992
Date Received
April 14, 1992
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

Other clearances by Bacton Assay Systems, Inc.

  • K921795 — BACTON(TM), AUTO-APO A-1 REAGENT (June 23, 1992)

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