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FDA 510(k)

BACTICARD CANDIDA

K-Number: K935124 · 1994-02-25

ApplicantRemel Co.
Decision Date1994-02-25
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTICARD CANDIDA is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K935124. 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 BACTICARD CANDIDA?

BACTICARD CANDIDA is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Remel Co.. The 510(k) number is K935124.

When did BACTICARD CANDIDA receive FDA 510(k) clearance?

BACTICARD CANDIDA received FDA 510(k) clearance on 1994-02-25, under 510(k) number K935124.

Who is the listed applicant for BACTICARD CANDIDA?

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

What is the FDA product code for BACTICARD CANDIDA?

The FDA product code for BACTICARD CANDIDA is JXB.

Related Clinical Trials

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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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.K943621RAPID YEAST PLUS SYSTEMInnovative Diagnostic Systems, Inc.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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