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510(k) K820705

GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL by United Diagnostics, Inc. — Product Code JJS

K820705 is an FDA 510(k) premarket notification submitted by United Diagnostics, Inc. for the device "GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL". The FDA issued a decision of Substantially Equivalent on April 1, 1982. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. United Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1982
Date Received
March 16, 1982
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 United Diagnostics, Inc.

  • K884977 — GAS TRAK PLUS (January 27, 1989)
  • K862278 — GAS-TRAK (August 4, 1986)
  • K844018 — GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (November 27, 1984)
  • K843986 — STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 (November 27, 1984)
  • K831389 — STAT-TRAK LIQUID ELECTROLYTE CONTROL (August 10, 1983)
  • K831814 — CALIBRATION STANDARD-HEMOGLOBIN (July 28, 1983)
  • K831813 — CO-OXIMETER CONTROL (July 28, 1983)
  • K831075 — BLOOD GAS & FLAME PHOTOMETER INSTRU- (June 22, 1983)
  • K813517 — BLOOD GAS ANALYSIS, STANDARDS CONTROLS (December 31, 1981)
  • K810618 — AMPULED FLAME PHOTOMETER STANDARDS (March 31, 1981)

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)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (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)
  • K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (September 25, 2000)

FDA data resources