Fluorometer

FDA product code JZT · Class I (low risk) · 21 CFR 866.4520 · Immunology

14510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

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
K864699Fluorescence Concentration Analyzer (Fca)JZT · Traditional Pandex Laboratories, Inc.12/22/1986SE
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
K800698Autofluor SystemJZT · Traditional California Immuno Diagnostic, Inc.05/28/1980SE
K782150Flurometer, DadeJZT · Traditional Dade, Baxter Travenol Diagnostics, Inc.02/15/1979SE
K770662Viewer, Fluorometic, Model 721JZT · Traditional Corning Medical & Scientific04/15/1977SE