510(k) K831908
- Device
- RABBIT ANTISERUM TO HUMAN IGG
- Applicant
- DAKO CORP.
- 510(k) number
- K831908
- Product code
- DGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-18
- Date received
- 1983-06-14
- Regulation
- 866.5510
- Classification name
- Igg, 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#
- 9610099
- 3013059683
- 3003423869
- 3009189893
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DGK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831609 | FIAX IGG TEST KIT | Intl. Diagnostic Technology | 1983-06-17 |
Legacy Summary#
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FDA Review#
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