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FDA 510(k)

GAP-IGG

K-Number: K900343 · 1991-08-22

ApplicantBiomerica, Inc.
Decision Date1991-08-22
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GAP-IGG is the device name listed in this FDA 510(k) record. The listed applicant is Biomerica, Inc.. It received FDA 510(k) clearance on 1991-08-22 under 510(k) number K900343. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAP-IGG?

GAP-IGG is a medical device that received FDA 510(k) clearance on 1991-08-22. The listed applicant is Biomerica, Inc.. The 510(k) number is K900343.

When did GAP-IGG receive FDA 510(k) clearance?

GAP-IGG received FDA 510(k) clearance on 1991-08-22, under 510(k) number K900343.

Who is the listed applicant for GAP-IGG?

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

What is the FDA product code for GAP-IGG?

The FDA product code for GAP-IGG is LYR.

Other records listing Biomerica, 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: LYR)

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.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, 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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