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FDA 510(k)

VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST

K-Number: K905787 · 1991-04-29

ApplicantVitek Systems, Inc.
Decision Date1991-04-29
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST 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 1991-04-29 under 510(k) number K905787. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST?

VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K905787.

When did VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST receive FDA 510(k) clearance?

VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST received FDA 510(k) clearance on 1991-04-29, under 510(k) number K905787.

Who is the listed applicant for VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST?

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 VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST?

The FDA product code for VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST is LJC.

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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: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, 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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