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510(k) K991108

CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 by A.P. Total Care, Inc. — Product Code KHS

K991108 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01". The FDA issued a decision of Substantially Equivalent on May 25, 1999. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1999
Date Received
April 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by A.P. Total Care, Inc.

  • K991246 — FRUCTOSAMINE, MODEL FR 106-01 (December 16, 1999)
  • K991761 — MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (September 2, 1999)
  • K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (September 2, 1999)
  • K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (August 19, 1999)
  • K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (August 10, 1999)
  • K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (August 2, 1999)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (July 30, 1999)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (June 30, 1999)
  • K991663 — AST/SGOT (June 30, 1999)

Other clearances for product code KHS

  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (March 11, 2014)
  • K131546 — AU BICARBONATE REAGENT (October 9, 2013)
  • K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REA (May 2, 2013)
  • K120765 — VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (October 24, 2012)
  • K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILI (July 2, 2012)
  • K111960 — ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE (November 18, 2011)
  • K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 (December 15, 2010)
  • K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, (May 10, 2010)

FDA data resources