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510(k) K002536

LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) by Bio-Rad — Product Code JJS

K002536 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)". The FDA issued a decision of Substantially Equivalent on August 30, 2000. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2000
Date Received
August 16, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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 JJS

  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)
  • K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL (March 15, 2013)
  • K033063 — MISSION CONTROLS (December 12, 2003)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (August 15, 2002)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (November 30, 2000)
  • K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (November 30, 2000)
  • K002866 — LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (September 25, 2000)

FDA data resources