Fiax Iga Test Kit
FDA 510(k) K831607 · Intl. Diagnostic Technology
510(k) numberK831607
Submission
- Device name
- Fiax Iga Test Kit
- Applicant
- Intl. Diagnostic Technology
Mchenry, IL, US - Received
- May 18, 1983
- Decision date
- June 22, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZN – Iga, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891683 | Titan Gel Ife Free Kappa/Lamba Light Chain AntiserCZN · Traditional | Helena Laboratories | 04/12/1989SE |
| K855011 | Quantimetric Plus C3 Reagent KitCZN · Traditional | Kallestad Laboratories, Inc. | 02/26/1986SE |
| K841815 | Optimate Iga TestCZN · Traditional | Miles Laboratories, Inc. | 06/01/1984SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | Gelco Diagnostics, Inc. | 10/31/1983SE |
| K832257 | Goat Anti-Human Iga a Chain SpecificCZN · Traditional | Gelco Diagnostics, Inc. | 10/28/1983SE |
| K831909 | Rabbit Antiserum to Human IgaCZN · Traditional | Dako Corp. | 07/18/1983SE |
More from Dako Corp.
| 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 |
| K840867 | ALPHA-1-ANTITRYPSIN, Fitc, AntigenDEI · Traditional | 05/11/1984SE |
| K834140 | Antinuclear Antibody Immunological SysKTL · Traditional | 01/20/1984SE |
| K833984 | Antinuclear Antibody ImmunologicalKTL · Traditional | 01/04/1984SE |
Questions and answers
When was Fiax Iga Test Kit cleared by the FDA?
Fiax Iga Test Kit (K831607) received a 510(k) decision of Substantially Equivalent on June 22, 1983, 35 days after the submission was received.
What is the product code of K831607?
The FDA product code is CZN – Iga, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.