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FDA 510(k)

ALLERGENETICS FLUORO-FAST READER

K-Number: K831870 · 1983-08-12

ApplicantAxonics, Inc.
Decision Date1983-08-12
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLERGENETICS FLUORO-FAST READER is the device name listed in this FDA 510(k) record. The listed applicant is Axonics, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831870. 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 ALLERGENETICS FLUORO-FAST READER?

ALLERGENETICS FLUORO-FAST READER is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Axonics, Inc.. The 510(k) number is K831870.

When did ALLERGENETICS FLUORO-FAST READER receive FDA 510(k) clearance?

ALLERGENETICS FLUORO-FAST READER received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831870.

Who is the listed applicant for ALLERGENETICS FLUORO-FAST READER?

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

What is the FDA product code for ALLERGENETICS FLUORO-FAST READER?

The FDA product code for ALLERGENETICS FLUORO-FAST READER 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 Axonics, 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.

K843712AUDIT TM VK833298AUDIT V AX 135K822335AUDITK823494TOTAL IGE-FAST TEST

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.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.

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