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FDA 510(k)

FLUORESCENCE CONCENTRATION ANALYZER (FCA)

K-Number: K864699 · 1986-12-22

ApplicantPandex Laboratories, Inc.
Decision Date1986-12-22
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCENCE CONCENTRATION ANALYZER (FCA) is the device name listed in this FDA 510(k) record. The listed applicant is Pandex Laboratories, Inc.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K864699. 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 FLUORESCENCE CONCENTRATION ANALYZER (FCA)?

FLUORESCENCE CONCENTRATION ANALYZER (FCA) is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Pandex Laboratories, Inc.. The 510(k) number is K864699.

When did FLUORESCENCE CONCENTRATION ANALYZER (FCA) receive FDA 510(k) clearance?

FLUORESCENCE CONCENTRATION ANALYZER (FCA) received FDA 510(k) clearance on 1986-12-22, under 510(k) number K864699.

Who is the listed applicant for FLUORESCENCE CONCENTRATION ANALYZER (FCA)?

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

What is the FDA product code for FLUORESCENCE CONCENTRATION ANALYZER (FCA)?

The FDA product code for FLUORESCENCE CONCENTRATION ANALYZER (FCA) 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 Pandex Laboratories, 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.

K852240SMS, SCREEN MACHINE SYSTEM

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 MedicalK863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, 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.

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