510(k) K772250
- Device
- ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
- Applicant
- KALLESTAD LABORATORIES, INC.
- 510(k) number
- K772250
- Product code
- DEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-12-22
- Date received
- 1977-12-09
- Regulation
- 866.5130
- Classification name
- Alpha-1-antitrypsin, 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | Intl. Diagnostic Technology | 1984-05-11 |
Legacy Summary#
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FDA Review#
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