IDS STAPHYLOCHROME TEST— 510(k) K822144

Name: FDA 510(k) clearance K822144
Creator: U.S. Food and Drug Administration
Published: 1982-08-24

Substantially Equivalent

Innovative Diagnostic Systems, Inc.

FDA 510(k) clearance K822144 for IDS STAPHYLOCHROME TEST, Substantially Equivalent on 1982-08-24. Applicant: Innovative Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Innovative Diagnostic Systems, Inc.
Product code: Code JWX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1982-07-21
Decision date: 1982-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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