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FDA 510(k)

BACTIDROP(TM) MUCAP

K-Number: K930878 · 1993-05-11

ApplicantRemel Co.
Decision Date1993-05-11
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIDROP(TM) MUCAP is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K930878. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIDROP(TM) MUCAP?

BACTIDROP(TM) MUCAP is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Remel Co.. The 510(k) number is K930878.

When did BACTIDROP(TM) MUCAP receive FDA 510(k) clearance?

BACTIDROP(TM) MUCAP received FDA 510(k) clearance on 1993-05-11, under 510(k) number K930878.

Who is the listed applicant for BACTIDROP(TM) MUCAP?

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 BACTIDROP(TM) MUCAP?

The FDA product code for BACTIDROP(TM) MUCAP is JTO.

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: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic 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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