GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90— 510(k) K972576

Name: FDA 510(k) clearance K972576
Creator: U.S. Food and Drug Administration
Published: 1998-01-22

Substantially Equivalent

Accumed Intl., Inc.

FDA 510(k) clearance K972576 for GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90, Substantially Equivalent on 1998-01-22. Applicant: Accumed Intl., Inc.. Device class: 1.

Clearance details

Applicant: Accumed Intl., Inc.
Product code: Code LQL
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1997-07-10
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

Download summary PDF View on FDA.gov ↗

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