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510(k) K992002

AUTOHDL CHOLESTEROL REAGENT SET by Pointe Scientific, Inc., — Product Code LBR

K992002 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "AUTOHDL CHOLESTEROL REAGENT SET". The FDA issued a decision of Substantially Equivalent on Aug 5, 1999. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Pointe Scientific, Inc., has 73 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 5, 1999
Date Received
Jun 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type
510(k) Exempt

Other clearances by Pointe Scientific, Inc.,

  • K070757 — MICROPROTEIN REAGENT SET (Dec 4, 2007)
  • K062118 — POINTE 360 (Jul 13, 2007)
  • K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT (Apr 30, 2007)
  • K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR (Apr 13, 2007)
  • K070504 — AMMONIA/ALCOHOL CONTROL SET (Apr 11, 2007)
  • K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (Mar 28, 2007)
  • K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (Oct 7, 2005)
  • K040391 — TOTAL BILIRUBIN REAGENT SET (Jun 2, 2004)
  • K031539 — HEMOGLOBIN A1C REAGENT SET (Aug 6, 2003)
  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (Apr 28, 2003)

Other clearances for product code LBR

  • K143691 — LDLC3 LDL-Cholesterol Gen.3 (Jan 28, 2015)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (Jan 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (Jul 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA… (Dec 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY… (Aug 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (Aug 12, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (Jul 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (Jan 28, 1999)
  • K980772 — HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (Apr 27, 1998)

FDA data resources

Source: FDA 510(k) database entry for K992002. Report a data issue: hello@regdatalab.com.