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FDA 510(k)

VIDAS CHLAMYDIA BLOCKING ASSAY

K-Number: K955627 · 1996-10-07

ApplicantBiomerieux Vitek, Inc.
Decision Date1996-10-07
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS CHLAMYDIA BLOCKING ASSAY 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 1996-10-07 under 510(k) number K955627. 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 BLOCKING ASSAY?

VIDAS CHLAMYDIA BLOCKING ASSAY is a medical device that received FDA 510(k) clearance on 1996-10-07. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K955627.

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

VIDAS CHLAMYDIA BLOCKING ASSAY received FDA 510(k) clearance on 1996-10-07, under 510(k) number K955627.

Who is the listed applicant for VIDAS CHLAMYDIA BLOCKING ASSAY?

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 VIDAS CHLAMYDIA BLOCKING ASSAY?

The FDA product code for VIDAS CHLAMYDIA BLOCKING ASSAY is LJC.

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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 ASSAYK962549VIDAS CREATINE KINASE MB ASSAY 30-421K962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

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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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