Fluorescence Concentration Analyzer (Fca)

FDA 510(k) K864699 · Pandex Laboratories, Inc.

Substantially Equivalent

510(k) numberK864699

Submission

Device name
Fluorescence Concentration Analyzer (Fca)
Applicant
Pandex Laboratories, Inc.
Mundelein, IL, US
Received
December 2, 1986
Decision date
December 22, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JZT – Fluorometer
Device class
Class I (low risk)
Regulation
21 CFR 866.4520
Specialty
Immunology

Other 510(k)s with product code JZT

510(k)DeviceApplicantDecision
K962499Zymmune Autoreader-F Fluorescence Microplate ReaderJZT · Traditional Bartels, Inc.09/05/1996SE
K883349Qlia Immunochemistry SystemJZT · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic09/07/1988SE
K882677STAT-20 FluorometerJZT · Traditional Weaver Medical07/12/1988SE
K863434The Fiax 5000 FluorometerJZT · Traditional Whittaker Bioproducts, Inc.10/29/1986SE
K862674Photon Elite/Automated Random Access Im/Ch SystemJZT · Traditional Hybritech, Inc.08/15/1986SE
K852240SMS, Screen Machine SystemJZT · Traditional Pandex Laboratories, Inc.06/11/1985SE
K842049FluoroskanJZT · Traditional Flow Laboratories, Inc.12/03/1984SE
K843356Fiax 100 FluorometerJZT · Traditional Intl. Diagnostic Technology09/17/1984SE
K834070Immpulse SystemJZT · Traditional Paragon Diagnostics, Inc.03/23/1984SE
K831870Allergenetics Fluoro-Fast ReaderJZT · Traditional Axonics, Inc.08/12/1983SE

More from Axonics, Inc.

510(k)DeviceDecision
K852240SMS, Screen Machine SystemJZT · Traditional 06/11/1985SE

Questions and answers

When was Fluorescence Concentration Analyzer (Fca) cleared by the FDA?

Fluorescence Concentration Analyzer (Fca) (K864699) received a 510(k) decision of Substantially Equivalent on December 22, 1986, 20 days after the submission was received.

What is the product code of K864699?

The FDA product code is JZT – Fluorometer, a Class I (low risk) device regulated under 21 CFR 866.4520.