510(k) K833841
- Device
- Il Test Igg Iga & Igm Kits
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K833841
- Product code
- CZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-04
- Date received
- 1983-11-07
- Regulation
- 866.5510
- Classification name
- Iga, Rhodamine, 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