PREMIER EHEC— 510(k) K950167

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K950167 for PREMIER EHEC, Substantially Equivalent on 1995-04-14. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1995-01-17
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Meridian Diagnostics, Inc.

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K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST1999-06-25
K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.