Fiax Igm Test Kit
FDA 510(k) K831608 · Intl. Diagnostic Technology
510(k) numberK831608
Submission
- Device name
- Fiax Igm 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
- DFT – Igm, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983132 | IgmDFT · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962201 | Quantex IgmDFT · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955797 | Igm Immunotrubidimetric & CalibratorDFT · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | Beckman-Diagnostic Systems Group | 12/12/1994SE |
| K901453 | Quik-Sep(R) Igm Rprotein G Affinity MethodDFT · Traditional | Isolab, Inc. | 04/12/1990SE |
| K894417 | Raichem(Tm) Spia(Tm) Igm ReagentsDFT · Traditional | Reagents Applications, Inc. | 08/02/1989SE |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | Orion Diagnostica, Inc. | 10/27/1988SE |
| K880828 | Wako(Tm) Igm-Ha DirectDFT · Traditional | Wako Chemicals USA, Inc. | 03/25/1988SE |
| K873871 | Immunoglobulins MDFT · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K872237 | Kallestad QM300 Igm Antibody PackDFT · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/09/1987SE |
More from Kallestad Diag, A Div. of Erbamont, 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 |
| 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 Igm Test Kit cleared by the FDA?
Fiax Igm Test Kit (K831608) 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 K831608?
The FDA product code is DFT – Igm, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.