Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
FDA 510(k) clearance K150791 · decided 2015-04-24
Clearance details
- K-number
- K150791
- Device name
- Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
- Applicant
- Healgen Scientific,, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-03-25
- Decision date
- 2015-04-24
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DIS
- Device class
- 2
- Regulation number
- 862.3150
- 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.