MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
FDA 510(k) clearance K063545 · decided 2007-05-07
Clearance details
- K-number
- K063545
- Device name
- MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
- Applicant
- Alfa Scientific Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-24
- Decision date
- 2007-05-07
- Days to decision
- 164 days
- Clearance type
- Abbreviated
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Powat, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.