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510(k) K820025

TRACE ANALYTICAL REDUCTION GAS ANALYZ by Trace Analytical — Product Code KZQ

K820025 is an FDA 510(k) premarket notification submitted by Trace Analytical for the device "TRACE ANALYTICAL REDUCTION GAS ANALYZ". The FDA issued a decision of Substantially Equivalent on February 15, 1982. The device falls under product code KZQ (Chromatography(Gas), Clinical Use), a Class I device regulated under 21 CFR 862.2250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1982
Date Received
January 5, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography(Gas), Clinical Use
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type

Other clearances for product code KZQ

  • K872122 — 8000 SERIES GAS CHROMATOGRAPHS (June 17, 1987)
  • K841891 — VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (July 9, 1984)
  • K832962 — GAS CHROMATOGRAPH 5890A (October 28, 1983)
  • K831387 — HS-100 HEADSPACE SAMPLING ACCESSORY (August 24, 1983)
  • K830147 — SIGMA 300 GAS CHROMATROGRAPH (February 7, 1983)
  • K820283 — SIGMA 2000 GAS CHROMATOGRAPH (February 23, 1982)
  • K820071 — MODEL 5790 GAS CHROMATOGRAPH (January 28, 1982)
  • K801745 — VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (August 20, 1980)
  • K791138 — 5880 SERIES OF GAS CHROMATOGRAPHS (July 24, 1979)
  • K770639 — DETECTOR, IR, MODEL GC-33 (June 24, 1977)

FDA data resources