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510(k) K843568

LIQUID CHROMATOGRAPH 400 by The Perkin-Elmer Corp. — Product Code KZR

K843568 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "LIQUID CHROMATOGRAPH 400". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), a Class I device regulated under 21 CFR 862.2260. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1984
Date Received
September 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography (Liquid, Gel), Clinical Use
Device Class
Class I
Regulation Number
862.2260
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 KZR

  • K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (October 6, 1997)
  • K931227 — USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (May 6, 1993)
  • K905538 — COLUMNS LIQUID CHROMATOGRAPHY DPM (January 25, 1991)
  • K861392 — SYVA SOLID PHASE COLUMNS SYSTEM II (June 13, 1986)
  • K860197 — SERIES 410 LC PUMP (March 17, 1986)
  • K851945 — VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (May 24, 1985)
  • K841890 — VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY (June 14, 1984)
  • K840977 — LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (April 19, 1984)
  • K832201 — CHROM-PREP (August 16, 1983)
  • K802725 — VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (December 11, 1980)

FDA data resources