PRECISET DAT AMPHETAMINE
FDA 510(k) clearance K030826 · decided 2003-04-03
Clearance details
- K-number
- K030826
- Device name
- PRECISET DAT AMPHETAMINE
- Applicant
- Quantimetrix Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-14
- Decision date
- 2003-04-03
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- DIJ
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Redondo Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELVI-AMINOLEVULINIC ACID (K792407) | Volu Sol Medical Industries | 1980-01-16 |
Recalls involving this device
No recalls on record reference this clearance.