Home / 510(k) Clearances / K882488

510(k) K882488

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES by Canyon Diagnostics, Inc. — Product Code LBR

K882488 is an FDA 510(k) premarket notification submitted by Canyon Diagnostics, Inc. for the device "CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES". The FDA issued a decision of Substantially Equivalent on August 15, 1988. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Canyon Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1988
Date Received
June 16, 1988
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 Canyon Diagnostics, Inc.

  • K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (February 11, 1997)
  • K964640 — CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-9 (December 13, 1996)
  • K871537 — CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II (May 6, 1987)
  • K854931 — CANTROL ELECTROPHORESIS CONTROL (January 17, 1986)
  • K855006 — CANTROL CK/MB CONTROL (January 17, 1986)
  • K854190 — CANTROL SPINAL FLUID CONTROL (November 25, 1985)
  • K853603 — CANTROL URINE DIPSTICK CONTROL TWO LEVELS (October 8, 1985)
  • K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (June 13, 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