510(k) K831904
- Device
- RABBIT ANTISERUM TO HUMAN KAPPA LIGHT
- Applicant
- DAKO CORP.
- 510(k) number
- K831904
- Product code
- DEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-19
- Date received
- 1983-06-14
- Regulation
- 866.5550
- Classification name
- Kappa, Fitc, 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#
- 9610099
- 3013059683
- 3003423869
- 3009189893
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832260 | GOAT ANTI-HUMAN KAPPA AFFINITY | Gelco Diagnostics, Inc. | 1983-10-31 |
Legacy Summary#
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FDA Review#
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