Home / 510(k) Clearances / K942451

510(k) K942451

BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM by Bio-Rad — Product Code LDM

K942451 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 1994. The device falls under product code LDM (Instrumentation, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
May 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, High Pressure Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code LDM

  • K960392 — CDM (July 8, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)
  • K884886 — MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (February 2, 1989)
  • K872582 — HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (July 16, 1987)
  • K870949 — WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (April 22, 1987)
  • K862178 — ISOPURE LC SYSTEM (July 14, 1986)
  • K850272 — WATERS 740 DATA MODULE-PLOTTER INTEGRATOR (March 6, 1985)

FDA data resources