510(k) K781951
- Device
- ANTISERA, RHODAMINE CONJUGATED FRAGMENT
- Applicant
- KALLESTAD LABORATORIES, INC.
- 510(k) number
- K781951
- Product code
- DCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-16
- Date received
- 1978-11-21
- Regulation
- 866.5520
- Classification name
- Fab, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- 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 DCE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K772128 | FLUORESCEIN CONJUGATED | Kallestad Laboratories, Inc. | 1977-11-22 |
Legacy Summary#
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FDA Review#
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