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FDA 510(k)

RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA

K-Number: K910304 · 1991-07-26

ApplicantVitek Systems, Inc.
Decision Date1991-07-26
Product CodeLQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K910304. 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 RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA?

RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K910304.

When did RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA receive FDA 510(k) clearance?

RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA received FDA 510(k) clearance on 1991-07-26, under 510(k) number K910304.

Who is the listed applicant for RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA?

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

What is the FDA product code for RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA?

The FDA product code for RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA is LQL.

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Other records listing Vitek Systems, Inc. as applicant

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K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

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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 SystemsK952095VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)Biomerieux Vitek, Inc.K925916VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDBiomerieux Vitek, 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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