510(k) K863868
- Device
- IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
- Applicant
- COOPERBIOMEDICAL, INC.
- 510(k) number
- K863868
- Product code
- DFF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-13
- Date received
- 1986-10-03
- Regulation
- 866.5080
- Classification name
- Alpha-1-antichymotrypsin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BREWSTER, PHD
- Address
- One Technology Ct. Malvern PA US 19355 19355
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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