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FDA 510(k)

VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION

K-Number: K910666 · 1991-04-03

ApplicantVitek Systems, Inc.
Decision Date1991-04-03
Product CodeJSP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION 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 1991-04-03 under 510(k) number K910666. The device is classified under product code JSP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION?

VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K910666.

When did VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION receive FDA 510(k) clearance?

VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910666.

Who is the listed applicant for VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION?

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 VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION?

The FDA product code for VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION is JSP.

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Other records listing Vitek Systems, 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.

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: JSP)

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.

K945488LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945487LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K945489LYFO(TM) DIFFERENTIAL DISKMicrobiologics, Inc.K944528BBLCRYSTAL ANAEROBE ID SYSTEMBecton Dickinson Microbiology SystemsK900996VITEK ANAEROBE IDENTIFICATION CARDVitek Systems, Inc.K881380B. FRAGTEXAmerican Biomedical Products, 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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