SASI-DC1TS— 510(k) K970580

Substantially Equivalent

Substance Abuse Specialties, Inc.

FDA 510(k) clearance K970580 for SASI-DC1TS, Substantially Equivalent on 1997-04-17. Applicant: Substance Abuse Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Substance Abuse Specialties, Inc.
Product code: Code KDW
Device class: Class 1
Regulation: 21 CFR 864.3250
Advisory panel: Pathology
Date received: 1997-02-14
Decision date: 1997-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

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