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FDA 510(k)

GARNERELLA VAGINALIS IDENTIFICATION KIT

K-Number: K864244 · 1987-03-31

ApplicantMds Laboratories, Inc.
Decision Date1987-03-31
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GARNERELLA VAGINALIS IDENTIFICATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mds Laboratories, Inc.. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K864244. 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 GARNERELLA VAGINALIS IDENTIFICATION KIT?

GARNERELLA VAGINALIS IDENTIFICATION KIT is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Mds Laboratories, Inc.. The 510(k) number is K864244.

When did GARNERELLA VAGINALIS IDENTIFICATION KIT receive FDA 510(k) clearance?

GARNERELLA VAGINALIS IDENTIFICATION KIT received FDA 510(k) clearance on 1987-03-31, under 510(k) number K864244.

Who is the listed applicant for GARNERELLA VAGINALIS IDENTIFICATION KIT?

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

What is the FDA product code for GARNERELLA VAGINALIS IDENTIFICATION KIT?

The FDA product code for GARNERELLA VAGINALIS IDENTIFICATION KIT is JTO.

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Other records listing Mds Laboratories, 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.

K864241DNASE AGARK864242HEKTOEN ENTERIC AGARK864252THAYER-MARTIN JEMBECK864247MUELLER HINTON AGAR WITH 5% SHEEP BLOODK864249NORMAL SALINE STERILEK864243MACCONKEY AGAR

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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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