HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)— 510(k) K141647

Name: FDA 510(k) clearance K141647
Creator: U.S. Food and Drug Administration
Published: 2014-07-17

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K141647 for HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD), Substantially Equivalent on 2014-07-17. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2014-06-19
Decision date: 2014-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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