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510(k) K831758

FLOW-CALIBRATION MODULE by The Perkin-Elmer Corp. — Product Code BXW

K831758 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "FLOW-CALIBRATION MODULE". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code BXW (Calibrator, Volume, Gas), a Class I device regulated under 21 CFR 868.1870. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Volume, Gas
Device Class
Class I
Regulation Number
868.1870
Review Panel
AN
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 BXW

  • K853848 — RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (December 5, 1985)
  • K830898 — SYRINGE 500BC BE #7000 (May 16, 1983)
  • K812765 — DATASCRIBE #DS-40 (November 16, 1981)
  • K810290 — OHIO CAL-CHEK (February 12, 1981)
  • K760520 — CALIPERS, MCGAW SKINFOLD (November 12, 1976)

FDA data resources