URINOSCOPY FUNNEL
FDA 510(k) clearance K871671 · decided 1987-05-20
Clearance details
- K-number
- K871671
- Device name
- URINOSCOPY FUNNEL
- Applicant
- Portable Medical Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-28
- Decision date
- 1987-05-20
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GHO
- Device class
- 1
- Regulation number
- 864.6160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Solana 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 |
|---|---|---|
| EMATOLOGY DILUENT RESERVOIR CLOSURE (K770980) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.