510(k) K802284
- Device
- ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
- Applicant
- KALLESTAD LABORATORIES, INC.
- 510(k) number
- K802284
- Product code
- CZQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-23
- Date received
- 1980-09-19
- Regulation
- 866.5150
- Classification name
- Bence-jones Protein, 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CZQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812327 | KAPPA & LAMBDA BENCE JONES CONTROLS | Kallestad Laboratories, Inc. | 1981-09-01 |
Legacy Summary#
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FDA Review#
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