Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)— 510(k) K150096
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K150096 for Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2015-03-04. Applicant: Healgen Scientific,, LLC. Device class: 2.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellaire, TX, US
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