AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
FDA 510(k) clearance K061556 · decided 2006-07-21
Clearance details
- K-number
- K061556
- Device name
- AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
- Applicant
- Amedica Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-05
- Decision date
- 2006-07-21
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- LDJ
- Device class
- 2
- Regulation number
- 862.3870
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.