Home / 510(k) Clearances / K884864

510(k) K884864

PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO by The Perkin-Elmer Corp. — Product Code JJQ

K884864 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO". The FDA issued a decision of Substantially Equivalent on February 10, 1989. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1989
Date Received
November 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
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)
  • 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)
  • K862178 — ISOPURE LC SYSTEM (July 14, 1986)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)

FDA data resources