Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k) clearance K152269 · decided 2015-09-09
Clearance details
- K-number
- K152269
- Device name
- Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
- Applicant
- Healgen Scientific,, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-08-11
- Decision date
- 2015-09-09
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Bellaire, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.