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510(k) K760769

TEMPERATURE REGULATED FIVE CELL HOLDERS by The Perkin-Elmer Corp. — Product Code JRI

K760769 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "TEMPERATURE REGULATED FIVE CELL HOLDERS". The FDA issued a decision of Substantially Equivalent on November 30, 1976. The device falls under product code JRI (Cuvette, Thermostated), a Class I device regulated under 21 CFR 862.2050. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1976
Date Received
October 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuvette, Thermostated
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
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 JRI

  • K873656 — MEDATRON CUVETTE DISC (December 14, 1987)
  • K780888 — THERMO SET ELECTRONIC TEM. CONTROLLER (June 28, 1978)
  • K760197 — ACCUVETTE II (July 19, 1976)

FDA data resources