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FDA 510(k)

RAPID YEAST PLUS SYSTEM

K-Number: K943621 · 1995-01-27

ApplicantInnovative Diagnostic Systems, Inc.
Decision Date1995-01-27
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID YEAST PLUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K943621. 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 RAPID YEAST PLUS SYSTEM?

RAPID YEAST PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Innovative Diagnostic Systems, Inc.. The 510(k) number is K943621.

When did RAPID YEAST PLUS SYSTEM receive FDA 510(k) clearance?

RAPID YEAST PLUS SYSTEM received FDA 510(k) clearance on 1995-01-27, under 510(k) number K943621.

Who is the listed applicant for RAPID YEAST PLUS SYSTEM?

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

What is the FDA product code for RAPID YEAST PLUS SYSTEM?

The FDA product code for RAPID YEAST PLUS SYSTEM is JXB.

Related Clinical Trials

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Other records listing Innovative Diagnostic Systems, 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.

K962966IDS RAPID CB PLUS SYSTEMK900517RAPID NF SYSTEMK882960IDS RAPID ANA SYSTEMK881501MODIFIED IDS RAPID NH SYSTEMK852871IDS RAPID SS/U SYSTEMK852110IDS RAPID E PLUS SYSTEM

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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.K993554YEASTESTDiagnostic Markers, 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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