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FDA 510(k)

BIOMERIEUX RSV DIRECT IF KIT

K-Number: K912371 · 1991-09-23

ApplicantVitek Systems, Inc.
Decision Date1991-09-23
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOMERIEUX RSV DIRECT IF KIT 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 1991-09-23 under 510(k) number K912371. The device is classified under product code LKT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMERIEUX RSV DIRECT IF KIT?

BIOMERIEUX RSV DIRECT IF KIT is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K912371.

When did BIOMERIEUX RSV DIRECT IF KIT receive FDA 510(k) clearance?

BIOMERIEUX RSV DIRECT IF KIT received FDA 510(k) clearance on 1991-09-23, under 510(k) number K912371.

Who is the listed applicant for BIOMERIEUX RSV DIRECT IF KIT?

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 BIOMERIEUX RSV DIRECT IF KIT?

The FDA product code for BIOMERIEUX RSV DIRECT IF KIT is LKT.

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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: LKT)

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.

K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.K942173RSV ANTIGEN TESTNeogenexK912842RSV-MAB TESTGull Laboratories, Inc.K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter 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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