510(k) K842071
- Device
- FIAX TRANSFERRIN TEST KIT
- Applicant
- INTL. DIAGNOSTIC TECHNOLOGY
- 510(k) number
- K842071
- Product code
- DDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-11
- Date received
- 1984-05-23
- Regulation
- 866.5880
- Classification name
- Transferrin, 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | Gelman Instrument Co. | 1978-02-03 |
Legacy Summary#
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FDA Review#
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