510(k) K782116
- Device
- KETOSTEROID TEST, HYCEL-17
- Applicant
- HYCEL, INC.
- 510(k) number
- K782116
- Product code
- CCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-01-26
- Date received
- 1978-12-27
- Regulation
- 862.1430
- Classification name
- Zimmerman (spectrophotometric), 17-ketosteroids
- 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
Legacy Summary#
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FDA Review#
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