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510(k) K872464

ION TRAP DETECTOR (ITD) by The Perkin-Elmer Corp. — Product Code DOP

K872464 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "ION TRAP DETECTOR (ITD)". The FDA issued a decision of Substantially Equivalent on August 11, 1987. The device falls under product code DOP (Mass Spectrometer, Clinical Use), a Class I device regulated under 21 CFR 862.2860. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1987
Date Received
June 23, 1987
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 by The Perkin-Elmer Corp.

  • K935666 — PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (April 26, 1994)
  • K900828 — PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. (April 9, 1990)
  • K884864 — PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO (February 10, 1989)
  • K884886 — MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (February 2, 1989)
  • K872737 — PERKIN-ELMER LC235 DIODE ARRAY DETECTOR (September 18, 1987)
  • K871550 — PFI-20 POLARIZING FLUORIMETER (July 1, 1987)
  • K872122 — 8000 SERIES GAS CHROMATOGRAPHS (June 17, 1987)
  • K870661 — LIFEWATCH PLUS (March 9, 1987)
  • K862605 — MODULAR MASS SPECTROMETER (M.S.) (August 13, 1986)
  • K862178 — ISOPURE LC SYSTEM (July 14, 1986)

Other clearances for product code DOP

  • K992163 — ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (July 13, 1999)
  • K974322 — ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (December 16, 1997)
  • K880418 — INCOS 50 MASS SPECTROMETER (May 31, 1988)
  • K880090 — ION TRAP DETECTOR (March 15, 1988)
  • K880089 — FINNIGAN MAT TSQ-70 (February 11, 1988)
  • 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