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FDA 510(k)

MUMPS IGG ELISA TESTY

K-Number: K971857 · 1997-11-04

ApplicantGull Laboratories, Inc.
Decision Date1997-11-04
Product CodeLJY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUMPS IGG ELISA TESTY is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K971857. 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 ELISA TESTY?

MUMPS IGG ELISA TESTY is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K971857.

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

MUMPS IGG ELISA TESTY received FDA 510(k) clearance on 1997-11-04, under 510(k) number K971857.

Who is the listed applicant for MUMPS IGG ELISA TESTY?

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

What is the FDA product code for MUMPS IGG ELISA TESTY?

The FDA product code for MUMPS IGG ELISA TESTY is LJY.

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Other records listing Gull Laboratories, 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.K961204MUMPS IGG TESTZeus Scientific, 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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