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FDA 510(k)

COCCIDIOIDES IMMITIS, LATEX AGGLUTI

K-Number: K792690 · 1980-01-17

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-17
Product CodeGMG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COCCIDIOIDES IMMITIS, LATEX AGGLUTI is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K792690. The device is classified under product code GMG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCCIDIOIDES IMMITIS, LATEX AGGLUTI?

COCCIDIOIDES IMMITIS, LATEX AGGLUTI is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792690.

When did COCCIDIOIDES IMMITIS, LATEX AGGLUTI receive FDA 510(k) clearance?

COCCIDIOIDES IMMITIS, LATEX AGGLUTI received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792690.

Who is the listed applicant for COCCIDIOIDES IMMITIS, LATEX AGGLUTI?

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

What is the FDA product code for COCCIDIOIDES IMMITIS, LATEX AGGLUTI?

The FDA product code for COCCIDIOIDES IMMITIS, LATEX AGGLUTI is GMG.

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Other records listing Meridian Diagnostics, 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: GMG)

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.

K812189COCCIDIOIDES LATEX AGGLUTINATIONAmerican Scientific ProductsK791381COCCIDIODES (COCCI)Immuno-Mycologics, Inc.K782070REAGENT, COCCI LATEXI M, Inc.K760829COCCIDIOIDES MYCELIAL ANTIGENI M, 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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