510(k) K771793
- Device
- DHEA TEST SET
- Applicant
- WIEN LABORATORIES, INC.
- 510(k) number
- K771793
- Product code
- CIY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-02
- Date received
- 1977-09-22
- Regulation
- 862.1080
- Classification name
- Radioimmunoassay, Androsterone
- Medical specialty
- Clinical Chemistry
- Review panel
- Immunology
- 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
Legacy Summary#
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FDA Review#
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