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FDA 510(k)

HISTOPLASMA CAPSULATUM, ANTISERUM

K-Number: K792711 · 1980-01-17

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

Device Summary

HISTOPLASMA CAPSULATUM, ANTISERUM 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 K792711. The device is classified under product code GMJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOPLASMA CAPSULATUM, ANTISERUM?

HISTOPLASMA CAPSULATUM, ANTISERUM 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 K792711.

When did HISTOPLASMA CAPSULATUM, ANTISERUM receive FDA 510(k) clearance?

HISTOPLASMA CAPSULATUM, ANTISERUM received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792711.

Who is the listed applicant for HISTOPLASMA CAPSULATUM, ANTISERUM?

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 HISTOPLASMA CAPSULATUM, ANTISERUM?

The FDA product code for HISTOPLASMA CAPSULATUM, ANTISERUM is GMJ.

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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: GMJ)

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.

K830837LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.K813359MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGLAmerican Scientific ProductsK802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMNolan Biological Laboratories, Inc.K792701HISTOPLASMA CAPSULATUM, ANTIGENMeridian Diagnostics, Inc.K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEASTMeridian Diagnostics, Inc.K792708HISTOPLASMA CAPSULATUM, MYCELIAL PHASEMeridian 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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