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510(k) K864699

FLUORESCENCE CONCENTRATION ANALYZER (FCA) by Pandex Laboratories, Inc. — Product Code JZT

K864699 is an FDA 510(k) premarket notification submitted by Pandex Laboratories, Inc. for the device "FLUORESCENCE CONCENTRATION ANALYZER (FCA)". The FDA issued a decision of Substantially Equivalent on December 22, 1986. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Pandex Laboratories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1986
Date Received
December 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer
Device Class
Class I
Regulation Number
866.4520
Review Panel
IM
Submission Type

Other clearances by Pandex Laboratories, Inc.

  • K852240 — SMS, SCREEN MACHINE SYSTEM (June 11, 1985)

Other clearances for product code JZT

  • K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (September 5, 1996)
  • K883349 — QLIA IMMUNOCHEMISTRY SYSTEM (September 7, 1988)
  • K882677 — STAT-20 FLUOROMETER (July 12, 1988)
  • K863434 — THE FIAX 5000 FLUOROMETER (October 29, 1986)
  • K862674 — PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM (August 15, 1986)
  • K852240 — SMS, SCREEN MACHINE SYSTEM (June 11, 1985)
  • K842049 — FLUOROSKAN (December 3, 1984)
  • K843356 — FIAX 100 FLUOROMETER (September 17, 1984)
  • K834070 — IMMPULSE SYSTEM (March 23, 1984)
  • K831870 — ALLERGENETICS FLUORO-FAST READER (August 12, 1983)

FDA data resources