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510(k) K991733

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS by Schiapparelli Biosystems, Inc. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1999
Date Received
May 21, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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  • K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (October 20, 1997)
  • K971526 — ACE HDL-C REAGENT (May 21, 1997)
  • K954179 — HDL PRECIPITATING REAGENT (December 11, 1995)

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