Home / 510(k) Clearances / K893966

510(k) K893966

HDL PRECIPITATING REAGENT by Diagnostic Systems — Product Code LBR

K893966 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "HDL PRECIPITATING REAGENT". The FDA issued a decision of Substantially Equivalent on July 25, 1989. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1989
Date Received
June 2, 1989
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

Other clearances by Diagnostic Systems

  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (August 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (August 21, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (December 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (March 15, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (July 11, 1986)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (September 25, 1985)
  • K853533 — ABSORBANCE TEST SOLUTION (September 16, 1985)

Other clearances for product code LBR

  • K143691 — LDLC3 LDL-Cholesterol Gen.3 (January 28, 2015)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (July 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRO (August 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (August 12, 1999)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (August 5, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (January 28, 1999)

FDA data resources