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510(k) K974322

ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM by Europa Scientific, Ltd. — Product Code DOP

K974322 is an FDA 510(k) premarket notification submitted by Europa Scientific, Ltd. for the device "ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code DOP (Mass Spectrometer, Clinical Use), a Class I device regulated under 21 CFR 862.2860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
November 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mass Spectrometer, Clinical Use
Device Class
Class I
Regulation Number
862.2860
Review Panel
TX
Submission Type

Other clearances for product code DOP

  • K992163 — ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (July 13, 1999)
  • K880418 — INCOS 50 MASS SPECTROMETER (May 31, 1988)
  • K880090 — ION TRAP DETECTOR (March 15, 1988)
  • K880089 — FINNIGAN MAT TSQ-70 (February 11, 1988)
  • K872464 — ION TRAP DETECTOR (ITD) (August 11, 1987)
  • K854076 — MGA 2000 GAS ANALYSER (December 11, 1985)
  • K810938 — MASS SPECTROMETER-MEDSPECT II (April 23, 1981)
  • K770994 — FURNACE AUTOSAMPLER, MODEL 155 (August 22, 1977)
  • K770637 — MERCURY/HYDRIDE SYSTEM MHS-1 (June 23, 1977)

FDA data resources