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FDA 510(k)

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA

K-Number: K923903 · 1993-08-09

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-08-09
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA 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 1993-08-09 under 510(k) number K923903. The device is classified under product code LJY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA?

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA is a medical device that received FDA 510(k) clearance on 1993-08-09. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K923903.

When did VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA receive FDA 510(k) clearance?

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA received FDA 510(k) clearance on 1993-08-09, under 510(k) number K923903.

Who is the listed applicant for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA?

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 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA?

The FDA product code for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA is LJY.

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Other records listing Biomerieux Vitek, Inc. as applicant

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Related Devices (Code: LJY)

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.

K991274MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.K980059SERAQUEST MUMPS IGGQuest Intl., Inc.K971857MUMPS IGG ELISA TESTYGull Laboratories, Inc.K961204MUMPS IGG TESTZeus Scientific, Inc.K925209MUMPS STATBiowhittaker Molecular Applications, Inc.K897006PHARMACIA MUMPS IGG ELISAPharmacia Eni 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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