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FDA 510(k)

RIM GARDNERELLA VAGINALIS KIT

K-Number: K841460 · 1984-05-02

ApplicantAustin Biological Laboratories
Decision Date1984-05-02
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RIM GARDNERELLA VAGINALIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841460. 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 RIM GARDNERELLA VAGINALIS KIT?

RIM GARDNERELLA VAGINALIS KIT is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Austin Biological Laboratories. The 510(k) number is K841460.

When did RIM GARDNERELLA VAGINALIS KIT receive FDA 510(k) clearance?

RIM GARDNERELLA VAGINALIS KIT received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841460.

Who is the listed applicant for RIM GARDNERELLA VAGINALIS KIT?

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

What is the FDA product code for RIM GARDNERELLA VAGINALIS KIT?

The FDA product code for RIM GARDNERELLA VAGINALIS KIT is JTO.

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Other records listing Austin Biological Laboratories 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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIME

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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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