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510(k) K831075

BLOOD GAS & FLAME PHOTOMETER INSTRU- by United Diagnostics, Inc. — Product Code CGC

K831075 is an FDA 510(k) premarket notification submitted by United Diagnostics, Inc. for the device "BLOOD GAS & FLAME PHOTOMETER INSTRU-". The FDA issued a decision of Substantially Equivalent on June 22, 1983. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325. United Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gastrin
Device Class
Class I
Regulation Number
862.1325
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)
  • K820705 — GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL (April 1, 1982)
  • K813517 — BLOOD GAS ANALYSIS, STANDARDS CONTROLS (December 31, 1981)
  • K810618 — AMPULED FLAME PHOTOMETER STANDARDS (March 31, 1981)

Other clearances for product code CGC

  • K961276 — GASTRIN EIA MODEL 06B-555017 (May 30, 1996)
  • K842079 — GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (June 26, 1984)
  • K841963 — GASTRIN RIA (June 25, 1984)
  • K833489 — DPC GASTRIN KIT (January 30, 1984)
  • K821175 — GASTRIN RADIOIMMUNOASSAY KIT (125-I) (May 14, 1982)
  • K812727 — GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (November 5, 1981)
  • K812004 — GASTRIN RIA DIAGNOSTIC KIT (July 28, 1981)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
  • K771953 — GASTRIN RIA MODULE (January 20, 1978)

FDA data resources