ALPHA-1-ANTITRYPSIN, Fitc, Antigen
FDA 510(k) K840867 · Intl. Diagnostic Technology
510(k) numberK840867
Submission
- Device name
- ALPHA-1-ANTITRYPSIN, Fitc, Antigen
- Applicant
- Intl. Diagnostic Technology
Mchenry, IL, US - Received
- February 27, 1984
- Decision date
- May 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEI – Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Specialty
- Immunology
Other 510(k)s with product code DEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K772250 | ALPHA-1-ANTITRYPSIN Nephel. AssayDEI · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
More from Kallestad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850591 | Fiax Toxo-M Antibodies Test KitGLZ · Traditional | 04/30/1985SE |
| K843570 | Fiax Haptoglobin Test KitDAB · Traditional | 10/05/1984SE |
| K843621 | Fiax 420 DilutorJQW · Traditional | 09/28/1984SE |
| K843356 | Fiax 100 FluorometerJZT · Traditional | 09/17/1984SE |
| K842749 | Fiax Total Ige Test KitDGP · Traditional | 08/28/1984SE |
| K842071 | Fiax Transferrin Test KitDDI · Traditional | 07/11/1984SE |
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | 06/07/1984SE |
| K834140 | Antinuclear Antibody Immunological SysKTL · Traditional | 01/20/1984SE |
| K833984 | Antinuclear Antibody ImmunologicalKTL · Traditional | 01/04/1984SE |
| K832821 | Fiax Igg TestDFI · Traditional | 10/14/1983SE |
Questions and answers
When was ALPHA-1-ANTITRYPSIN, Fitc, Antigen cleared by the FDA?
ALPHA-1-ANTITRYPSIN, Fitc, Antigen (K840867) received a 510(k) decision of Substantially Equivalent on May 11, 1984, 74 days after the submission was received.
What is the product code of K840867?
The FDA product code is DEI – Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5130.