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FDA 510(k)

PERMIER HISTOPLASMA

K-Number: K915700 · 1992-07-30

ApplicantMeridian Diagnostics, Inc.
Decision Date1992-07-30
Product CodeMIZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PERMIER HISTOPLASMA 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 1992-07-30 under 510(k) number K915700. The device is classified under product code MIZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMIER HISTOPLASMA?

PERMIER HISTOPLASMA is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K915700.

When did PERMIER HISTOPLASMA receive FDA 510(k) clearance?

PERMIER HISTOPLASMA received FDA 510(k) clearance on 1992-07-30, under 510(k) number K915700.

Who is the listed applicant for PERMIER HISTOPLASMA?

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 PERMIER HISTOPLASMA?

The FDA product code for PERMIER HISTOPLASMA is MIZ.

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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: MIZ)

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.

K101407ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102Immuno-Mycologics, 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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