510(k) K874379
- Device
- CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
- Applicant
- CYTOTECH, INC.
- 510(k) number
- K874379
- Product code
- CZY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-25
- Date received
- 1987-10-26
- Regulation
- 866.5240
- Classification name
- Complement C1s, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIEHL, PHD
- Address
- 11035 Roselle St., Suite A San Diego CA US 92121 92121
FDA Registration Numbers#
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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