FDA 510(k)

FIAX 100 FLUOROMETER

K-Number: K843356 · 1984-09-17

Decision Date1984-09-17

Product CodeJZT

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

FIAX 100 FLUOROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1984-09-17 under 510(k) number K843356. The device is classified under product code JZT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX 100 FLUOROMETER?

FIAX 100 FLUOROMETER is a medical device that received FDA 510(k) clearance on 1984-09-17. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K843356.

When did FIAX 100 FLUOROMETER receive FDA 510(k) clearance?

FIAX 100 FLUOROMETER received FDA 510(k) clearance on 1984-09-17, under 510(k) number K843356.

Who is the listed applicant for FIAX 100 FLUOROMETER?

The FDA 510(k) record lists Intl. Diagnostic Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIAX 100 FLUOROMETER?

The FDA product code for FIAX 100 FLUOROMETER is JZT.

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Other records listing Intl. Diagnostic Technology as applicant

K850591FIAX TOXO-M ANTIBODIES TEST KIT K843570FIAX HAPTOGLOBIN TEST KIT K843621FIAX 420 DILUTOR K842749FIAX TOTAL IGE TEST KIT K842071FIAX TRANSFERRIN TEST KIT K841174RUBELLA ANTIBODY FLUOROIMMUNOASSAY

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Related Devices (Code: JZT)

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic K882677STAT-20 FLUOROMETERWeaver Medical K864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, Inc.K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.