GONORRHEA TRANSETTE 3— 510(k) K822886

Name: FDA 510(k) clearance K822886
Creator: U.S. Food and Drug Administration
Published: 1982-10-27

Substantially Equivalent

Spectrum Diagnostic, Inc.

FDA 510(k) clearance K822886 for GONORRHEA TRANSETTE 3, Substantially Equivalent on 1982-10-27. Applicant: Spectrum Diagnostic, Inc.. Device class: 1.

Clearance details

Applicant: Spectrum Diagnostic, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1982-09-28
Decision date: 1982-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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