510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864699Substantially Equivalent

Fluorescence Concentration Analyzer (Fca)

Pandex Laboratories, Inc., Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864699 is the FDA 510(k) clearance record for FLUORESCENCE CONCENTRATION ANALYZER (FCA), a class I device, cleared for Pandex Laboratories, Inc. on under FDA product code JZT (Fluorometer). FDA records list 2 510(k) clearances for Pandex Laboratories, Inc., from to . As of , FDA records show no recalls naming K864699.

Clearance record

Decision date
Received
(20 days to decision)
Product code
JZT Fluorometer
Regulation
21 CFR 866.4520
Device class
Class I
Review panel
Immunology
Applicant
Pandex Laboratories, Inc. 909 Orchard St., Mundelein IL
Third party review
No

Clearances, product code JZT

Trailing 12 months

FDA records hold no clearances under product code JZT in the trailing twelve months.

FDA records show no clearances under product code JZT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JZT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260