SMS, Screen Machine System

FDA 510(k) K852240 · Pandex Laboratories, Inc.

Substantially Equivalent

510(k) numberK852240

Submission

Device name
SMS, Screen Machine System
Applicant
Pandex Laboratories, Inc.
Mundelein, IL, US
Received
May 23, 1985
Decision date
June 11, 1985
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
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
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
K864699Fluorescence Concentration Analyzer (Fca)JZT · Traditional 12/22/1986SE

Questions and answers

When was SMS, Screen Machine System cleared by the FDA?

SMS, Screen Machine System (K852240) received a 510(k) decision of Substantially Equivalent on June 11, 1985, 19 days after the submission was received.

What is the product code of K852240?

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