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FDA 510(k)

MUMPS IGG TEST

K-Number: K961204 · 1996-07-18

ApplicantZeus Scientific, Inc.
Decision Date1996-07-18
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUMPS IGG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K961204. 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 IGG TEST?

MUMPS IGG TEST is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K961204.

When did MUMPS IGG TEST receive FDA 510(k) clearance?

MUMPS IGG TEST received FDA 510(k) clearance on 1996-07-18, under 510(k) number K961204.

Who is the listed applicant for MUMPS IGG TEST?

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

What is the FDA product code for MUMPS IGG TEST?

The FDA product code for MUMPS IGG TEST is LJY.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.K925209MUMPS STATBiowhittaker Molecular Applications, 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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