510(k) K854190
- Device
- CANTROL SPINAL FLUID CONTROL
- Applicant
- CANYON DIAGNOSTICS, INC.
- 510(k) number
- K854190
- Product code
- DFI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-25
- Date received
- 1985-10-15
- Regulation
- 866.5860
- Classification name
- Total Spinal-fluid, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FALKOWSKI
- Address
- 4081 E. La Palma Ave., Unit F Anaheim CA US 92807 92807
FDA Registration Numbers#
- 9614373
- 3012471076
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DFI #
Legacy Summary#
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FDA Review#
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