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510(k) K821219

SERIES 4 LIQUID CHROMATOGRAPH by The Perkin-Elmer Corp. — Product Code LDM

K821219 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "SERIES 4 LIQUID CHROMATOGRAPH". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code LDM (Instrumentation, High Pressure Liquid Chromatography), 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
May 28, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrumentation, High Pressure Liquid Chromatography
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 LDM

  • K960392 — CDM (July 8, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)
  • K942451 — BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (November 10, 1994)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)
  • K884886 — MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (February 2, 1989)
  • K872582 — HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (July 16, 1987)
  • K870949 — WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM (April 22, 1987)
  • K862178 — ISOPURE LC SYSTEM (July 14, 1986)

FDA data resources