510(k) K831987
- Device
- Epsilon Ige Test Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K831987
- Product code
- DGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-06-21
- Regulation
- 866.5510
- Classification name
- Ige, Peroxidase, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3002806944
- 1036362
- 3006198300
Source Documents#
510(k) summary PDF not indicated by FDA
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