MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
FDA 510(k) clearance K013124 · decided 2001-11-07
Clearance details
- K-number
- K013124
- Device name
- MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
- Applicant
- Branan Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-19
- Decision date
- 2001-11-07
- Days to decision
- 49 days
- Clearance type
- Special
- Product code
- DJJ
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Branan Medical Corp.
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.
Recalls involving this device
No recalls on record reference this clearance.