SPUTASOL— 510(k) K802493

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K802493 for SPUTASOL, Substantially Equivalent on 1980-11-12. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code IBG
Device class: Class 1
Regulation: 21 CFR 864.4400
Advisory panel: Pathology
Date received: 1980-10-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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