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FDA 510(k)

PREMIER-CRYPTOCOCCAL ANTIGEN

K-Number: K904393 · 1991-01-25

ApplicantMeridian Diagnostics, Inc.
Decision Date1991-01-25
Product CodeMDU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER-CRYPTOCOCCAL ANTIGEN 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 1991-01-25 under 510(k) number K904393. The device is classified under product code MDU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER-CRYPTOCOCCAL ANTIGEN?

PREMIER-CRYPTOCOCCAL ANTIGEN is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K904393.

When did PREMIER-CRYPTOCOCCAL ANTIGEN receive FDA 510(k) clearance?

PREMIER-CRYPTOCOCCAL ANTIGEN received FDA 510(k) clearance on 1991-01-25, under 510(k) number K904393.

Who is the listed applicant for PREMIER-CRYPTOCOCCAL ANTIGEN?

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 PREMIER-CRYPTOCOCCAL ANTIGEN?

The FDA product code for PREMIER-CRYPTOCOCCAL ANTIGEN is MDU.

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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: MDU)

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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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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