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510(k) K810618

AMPULED FLAME PHOTOMETER STANDARDS by United Diagnostics, Inc. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1981
Date Received
March 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by United Diagnostics, Inc.

  • K884977 — GAS TRAK PLUS (January 27, 1989)
  • K862278 — GAS-TRAK (August 4, 1986)
  • K843986 — STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 (November 27, 1984)
  • K844018 — GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (November 27, 1984)
  • K831389 — STAT-TRAK LIQUID ELECTROLYTE CONTROL (August 10, 1983)
  • K831813 — CO-OXIMETER CONTROL (July 28, 1983)
  • K831814 — CALIBRATION STANDARD-HEMOGLOBIN (July 28, 1983)
  • K831075 — BLOOD GAS & FLAME PHOTOMETER INSTRU- (June 22, 1983)
  • K820705 — GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL (April 1, 1982)
  • K813517 — BLOOD GAS ANALYSIS, STANDARDS CONTROLS (December 31, 1981)

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