Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THE FIAX 5000 FLUOROMETER

K-Number: K863434 · 1986-10-29

ApplicantWhittaker Bioproducts, Inc.
Decision Date1986-10-29
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THE FIAX 5000 FLUOROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K863434. 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 THE FIAX 5000 FLUOROMETER?

THE FIAX 5000 FLUOROMETER is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K863434.

When did THE FIAX 5000 FLUOROMETER receive FDA 510(k) clearance?

THE FIAX 5000 FLUOROMETER received FDA 510(k) clearance on 1986-10-29, under 510(k) number K863434.

Who is the listed applicant for THE FIAX 5000 FLUOROMETER?

The FDA 510(k) record lists Whittaker Bioproducts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE FIAX 5000 FLUOROMETER?

The FDA product code for THE FIAX 5000 FLUOROMETER is JZT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Whittaker Bioproducts, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK905468PYLORI-G FIAX TEST KIT

View all 30 devices →

Related Devices (Code: JZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK882677STAT-20 FLUOROMETERWeaver MedicalK864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, Inc.K852240SMS, SCREEN MACHINE SYSTEMPandex Laboratories, 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.

↑