510(k) K790710
- Device
- ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN
- Applicant
- KENT LABORATORIES, INC.
- 510(k) number
- K790710
- Product code
- DDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-08-03
- Date received
- 1979-04-12
- Regulation
- 866.5620
- Classification name
- Alpha-2-macroglobulin, Fitc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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