Home / 510(k) Clearances / K874820

510(k) K874820

MULTICHEM HDL PRECIPITATING REAGENT #S0914 by Simmler, Inc. — Product Code LBR

K874820 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM HDL PRECIPITATING REAGENT #S0914". The FDA issued a decision of Substantially Equivalent on Jan 7, 1988. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Simmler, Inc. has 22 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 7, 1988
Date Received
Nov 24, 1987
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 Simmler, Inc.

  • K895745 — SICKLE CELL SOLUBILITY TEST KIT (Nov 29, 1989)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (Feb 11, 1988)
  • K874595 — MULTICHEM (R) MAGNESIUM REAGENT (Jan 21, 1988)
  • K874812 — MULTICHEM CHLORIDE REAGENT S0933 (Dec 18, 1987)
  • K874311 — MULTICHEM (R) TOTAL BILIRUBIN (Nov 25, 1987)
  • K874049 — MULTICHEM ALBUMIN REAGENT S0902 (Oct 29, 1987)
  • K874038 — MULTICHEM INORGANIC PHOSPHOROUS S0923 (Oct 28, 1987)
  • K873725 — MULTICHEM CREATININE REAGENT S0917 (Oct 20, 1987)
  • K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903) (Oct 7, 1987)
  • K873697 — MULTICHEM CALCIUM S0910 (Oct 2, 1987)

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)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (Aug 5, 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)

FDA data resources

Source: FDA 510(k) database entry for K874820. Report a data issue: hello@regdatalab.com.