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510(k) K971526

ACE HDL-C REAGENT by Schiapparelli Biosystems, Inc. — Product Code LBS

K971526 is an FDA 510(k) premarket notification submitted by Schiapparelli Biosystems, Inc. for the device "ACE HDL-C REAGENT". The FDA issued a decision of Substantially Equivalent on May 21, 1997. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl), a Class I device regulated under 21 CFR 862.1475. Schiapparelli Biosystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1997
Date Received
April 28, 1997
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 Schiapparelli Biosystems, Inc.

  • K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (July 13, 1999)
  • K981377 — ACE T4 REAGENT T4 CALIBRATORS (June 10, 1998)
  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K973581 — ACE VALPROIC ACID REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K973536 — ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (November 6, 1997)
  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (October 20, 1997)
  • K954179 — HDL PRECIPITATING REAGENT (December 11, 1995)

Other clearances for product code LBS

  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES (September 7, 2012)
  • K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER (September 27, 2011)
  • K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL (August 31, 2011)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)
  • K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
  • K100010 — HDL CHOLESTEROL (HDLX) ASSAY (May 14, 2010)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)

FDA data resources