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FDA 510(k)

MUMPS STAT

K-Number: K925209 · 1994-10-14

ApplicantBiowhittaker Molecular Applications, Inc.
Decision Date1994-10-14
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUMPS STAT is the device name listed in this FDA 510(k) record. The listed applicant is Biowhittaker Molecular Applications, Inc.. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K925209. 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 MUMPS STAT?

MUMPS STAT is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Biowhittaker Molecular Applications, Inc.. The 510(k) number is K925209.

When did MUMPS STAT receive FDA 510(k) clearance?

MUMPS STAT received FDA 510(k) clearance on 1994-10-14, under 510(k) number K925209.

Who is the listed applicant for MUMPS STAT?

The FDA 510(k) record lists Biowhittaker Molecular Applications, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MUMPS STAT?

The FDA product code for MUMPS STAT is LJY.

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Other records listing Biowhittaker Molecular Applications, 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.

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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.K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, 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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