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FDA 510(k)

PREMIER COCCIDIOIDES

K-Number: K915493 · 1992-07-10

ApplicantMeridian Diagnostics, Inc.
Decision Date1992-07-10
Product CodeMIY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER COCCIDIOIDES 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 1992-07-10 under 510(k) number K915493. The device is classified under product code MIY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER COCCIDIOIDES?

PREMIER COCCIDIOIDES is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K915493.

When did PREMIER COCCIDIOIDES receive FDA 510(k) clearance?

PREMIER COCCIDIOIDES received FDA 510(k) clearance on 1992-07-10, under 510(k) number K915493.

Who is the listed applicant for PREMIER COCCIDIOIDES?

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 COCCIDIOIDES?

The FDA product code for PREMIER COCCIDIOIDES is MIY.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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