AT HOME DRUG TEST, MODEL 9073 T
FDA 510(k) clearance K010650 · decided 2001-03-30
Clearance details
- K-number
- K010650
- Device name
- AT HOME DRUG TEST, MODEL 9073 T
- Applicant
- Phamatech
- Decision
- Substantially Equivalent
- Date received
- 2001-03-05
- Decision date
- 2001-03-30
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Phamatech
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.