URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
FDA 510(k) clearance K761271 · decided 1977-02-14
Clearance details
- K-number
- K761271
- Device name
- URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
- Applicant
- Eppendorf-Brinkmann, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-20
- Decision date
- 1977-02-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- CDB
- Device class
- 1
- Regulation number
- 862.1385
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| 17-HYDROXY TEST (K772426) | Hycel, Inc. | 1978-01-30 |
Recalls involving this device
No recalls on record reference this clearance.