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510(k) K820283

SIGMA 2000 GAS CHROMATOGRAPH by The Perkin-Elmer Corp. — Product Code KZQ

K820283 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "SIGMA 2000 GAS CHROMATOGRAPH". The FDA issued a decision of Substantially Equivalent on February 23, 1982. The device falls under product code KZQ (Chromatography(Gas), Clinical Use), a Class I device regulated under 21 CFR 862.2250. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1982
Date Received
February 2, 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 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)
  • K872464 — ION TRAP DETECTOR (ITD) (August 11, 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)

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)
  • K820025 — TRACE ANALYTICAL REDUCTION GAS ANALYZ (February 15, 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