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FDA 510(k)

BACTIDROP (TM) NITRATE B

K-Number: K913010 · 1991-09-19

ApplicantRemel Co.
Decision Date1991-09-19
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIDROP (TM) NITRATE B is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K913010. 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) NITRATE B?

BACTIDROP (TM) NITRATE B is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Remel Co.. The 510(k) number is K913010.

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

BACTIDROP (TM) NITRATE B received FDA 510(k) clearance on 1991-09-19, under 510(k) number K913010.

Who is the listed applicant for BACTIDROP (TM) NITRATE B?

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) NITRATE B?

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

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.

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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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