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510(k) K982539

HDLC PRECIPITATING REAGENT by Ac Biochemicals, Inc. — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1998
Date Received
July 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Ac Biochemicals, Inc.

  • K980012 — CREATINE KINASE REAGENT (February 25, 1998)
  • K980013 — AMYLASE (February 4, 1998)

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