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FDA 510(k)

MUMPSELISA TEST KIT

K-Number: K830045 · 1983-05-13

ApplicantM.A. Bioproducts
Decision Date1983-05-13
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUMPSELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1983-05-13 under 510(k) number K830045. 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 MUMPSELISA TEST KIT?

MUMPSELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1983-05-13. The listed applicant is M.A. Bioproducts. The 510(k) number is K830045.

When did MUMPSELISA TEST KIT receive FDA 510(k) clearance?

MUMPSELISA TEST KIT received FDA 510(k) clearance on 1983-05-13, under 510(k) number K830045.

Who is the listed applicant for MUMPSELISA TEST KIT?

The FDA 510(k) record lists M.A. Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MUMPSELISA TEST KIT?

The FDA product code for MUMPSELISA TEST KIT is LJY.

Related Clinical Trials

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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Other records listing M.A. Bioproducts 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.

K822883HERPELISA KITK823804MYCOPLASMELISA TEST KITK830615CYTOMEGELISA STATK823805VARICELISA TEST KITK821967CHLAMYDELISA TEST KITK821762MEASELISA TEST KIT

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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.K923903VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSABiomerieux Vitek, 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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