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FDA 510(k)

YEASTEST

K-Number: K993554 · 2000-02-10

ApplicantDiagnostic Markers, Inc.
Decision Date2000-02-10
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

YEASTEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Markers, Inc.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K993554. The device is classified under product code JXB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YEASTEST?

YEASTEST is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Diagnostic Markers, Inc.. The 510(k) number is K993554.

When did YEASTEST receive FDA 510(k) clearance?

YEASTEST received FDA 510(k) clearance on 2000-02-10, under 510(k) number K993554.

Who is the listed applicant for YEASTEST?

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

What is the FDA product code for YEASTEST?

The FDA product code for YEASTEST is JXB.

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

Related Devices (Code: JXB)

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.

K080719YEAST TRAFFIC LIGHT PNA FISHAdvandx, Inc.K062461C. ALBICANS PNA FISHAdvandx, Inc.K943621RAPID YEAST PLUS SYSTEMInnovative Diagnostic Systems, Inc.K935124BACTICARD CANDIDARemel Co.K900112MICRORING YTMedical Wire & Equipment Co.K881925VITEK YEAST BIOCHEMICAL CARDVitek Systems, 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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