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FDA 510(k)

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)

K-Number: K952095 · 1996-03-12

ApplicantBiomerieux Vitek, Inc.
Decision Date1996-03-12
Product CodeLQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K952095. The device is classified under product code LQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)?

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K952095.

When did VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) receive FDA 510(k) clearance?

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) received FDA 510(k) clearance on 1996-03-12, under 510(k) number K952095.

Who is the listed applicant for VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)?

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

What is the FDA product code for VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)?

The FDA product code for VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) is LQL.

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Other records listing Biomerieux Vitek, 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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Related Devices (Code: LQL)

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.

K972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90Accumed Intl., Inc.K961968BBLCRYSTAL GRAM-POSITIVE ID SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK961730RAPID GRAM-POSITIVE ID SYSTEMBecton Dickinson Microbiology SystemsK925916VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDBiomerieux Vitek, Inc.K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIAVitek Systems, Inc.K910537VISI-STREPKev Connecticut Diagnostics, 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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