510(k) K840867
- Device
- ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
- Applicant
- INTL. DIAGNOSTIC TECHNOLOGY
- 510(k) number
- K840867
- Product code
- DEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-11
- Date received
- 1984-02-27
- 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
- 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 DEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K772250 | ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 |
Legacy Summary#
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FDA Review#
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