510(k) K761271
- Device
- URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
- Applicant
- Eppendorf-Brinkmann, Inc.
- 510(k) number
- K761271
- Product code
- CDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-14
- Date received
- 1976-12-20
- Regulation
- 862.1385
- Classification name
- Porter Silber Hydrazone, 17-Hydroxycorticosteroids
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CDB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K772426 | 17-HYDROXY TEST | Hycel, Inc. | 1978-01-30 |