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FDA 510(k)

ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER

K-Number: K962499 · 1996-09-05

ApplicantBartels, Inc.
Decision Date1996-09-05
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER is the device name listed in this FDA 510(k) record. The listed applicant is Bartels, Inc.. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K962499. 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 ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER?

ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Bartels, Inc.. The 510(k) number is K962499.

When did ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER receive FDA 510(k) clearance?

ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER received FDA 510(k) clearance on 1996-09-05, under 510(k) number K962499.

Who is the listed applicant for ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER?

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

What is the FDA product code for ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER?

The FDA product code for ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE 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 Bartels, 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.

K942820H292

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.

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.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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