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FDA 510(k)

PREMIER EHEC

K-Number: K953362 · 1995-11-14

ApplicantMeridian Diagnostics, Inc.
Decision Date1995-11-14
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER EHEC 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 1995-11-14 under 510(k) number K953362. The device is classified under product code GNA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER EHEC?

PREMIER EHEC is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K953362.

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

PREMIER EHEC received FDA 510(k) clearance on 1995-11-14, under 510(k) number K953362.

Who is the listed applicant for PREMIER EHEC?

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 EHEC?

The FDA product code for PREMIER EHEC is GNA.

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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:H7K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: GNA)

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.

K071799MODIFICATION TO BIOSTAR OIA SHIGATOXIverness Medical Professional DiagnosticsK031367DUOPATH VEROTOXINS GLISA TESTEmd Chemicals, Inc.K993401DRYSPOT E.COLI 0157 KITOxoid , Ltd.K981734VTEC-RPLA SEIKENDenka Seiken'SK962028WELLCOLEX E-COLI OI57 ZC60Murex Diagnostics, Inc.K950167PREMIER EHECMeridian 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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