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FDA 510(k)

VIDAS CHLAMYDIA ASSAY, MODIFICATION

K-Number: K915884 · 1992-03-04

ApplicantVitek Systems, Inc.
Decision Date1992-03-04
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS CHLAMYDIA ASSAY, 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 1992-03-04 under 510(k) number K915884. 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, MODIFICATION?

VIDAS CHLAMYDIA ASSAY, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-03-04. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K915884.

When did VIDAS CHLAMYDIA ASSAY, MODIFICATION receive FDA 510(k) clearance?

VIDAS CHLAMYDIA ASSAY, MODIFICATION received FDA 510(k) clearance on 1992-03-04, under 510(k) number K915884.

Who is the listed applicant for VIDAS CHLAMYDIA ASSAY, 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 VIDAS CHLAMYDIA ASSAY, MODIFICATION?

The FDA product code for VIDAS CHLAMYDIA ASSAY, MODIFICATION 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 ASSAYK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAYK912371BIOMERIEUX RSV DIRECT IF KIT

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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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