ONE STEP MORPHINE CARD TEST— 510(k) K970579

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K970579 for ONE STEP MORPHINE CARD TEST, Substantially Equivalent on 1997-07-03. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code DNK
Device class: Class 2
Regulation: 21 CFR 862.3640
Advisory panel: Clinical Toxicology
Date received: 1997-02-14
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DNK

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