URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
FDA 510(k) clearance K912888 · decided 1992-02-24
Clearance details
- K-number
- K912888
- Device name
- URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
- Applicant
- Dynagen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-01
- Decision date
- 1992-02-24
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- MIG
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cambridge, MA, 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 |
|---|---|---|
| TUMORLOCALIZER MRI (K962615) | Ferguson Medical | 1998-03-19 |
Recalls involving this device
No recalls on record reference this clearance.