510(k) K772426
- Device
- 17-HYDROXY TEST
- Applicant
- HYCEL, INC.
- 510(k) number
- K772426
- Product code
- CDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-30
- Date received
- 1977-12-27
- 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
- No
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 |
|---|---|---|---|
| K761271 | URIN. L7-OH CORTICOSTEROID T(NON HYDRO) | Eppendorf-Brinkmann, Inc. | 1977-02-14 |
Legacy Summary#
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FDA Review#
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