Allergenetics Fluoro-Fast Reader
FDA 510(k) K831870 · Axonics, Inc.
510(k) numberK831870
Submission
- Device name
- Allergenetics Fluoro-Fast Reader
- Applicant
- Axonics, Inc.
Mchenry, IL, US - Received
- June 10, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZT – Fluorometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4520
- Specialty
- Immunology
Other 510(k)s with product code JZT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962499 | Zymmune Autoreader-F Fluorescence Microplate ReaderJZT · Traditional | Bartels, Inc. | 09/05/1996SE |
| K883349 | Qlia Immunochemistry SystemJZT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/07/1988SE |
| K882677 | STAT-20 FluorometerJZT · Traditional | Weaver Medical | 07/12/1988SE |
| K864699 | Fluorescence Concentration Analyzer (Fca)JZT · Traditional | Pandex Laboratories, Inc. | 12/22/1986SE |
| K863434 | The Fiax 5000 FluorometerJZT · Traditional | Whittaker Bioproducts, Inc. | 10/29/1986SE |
| K862674 | Photon Elite/Automated Random Access Im/Ch SystemJZT · Traditional | Hybritech, Inc. | 08/15/1986SE |
| K852240 | SMS, Screen Machine SystemJZT · Traditional | Pandex Laboratories, Inc. | 06/11/1985SE |
| K842049 | FluoroskanJZT · Traditional | Flow Laboratories, Inc. | 12/03/1984SE |
| K843356 | Fiax 100 FluorometerJZT · Traditional | Intl. Diagnostic Technology | 09/17/1984SE |
| K834070 | Immpulse SystemJZT · Traditional | Paragon Diagnostics, Inc. | 03/23/1984SE |
More from Paragon Diagnostics, Inc.
Questions and answers
When was Allergenetics Fluoro-Fast Reader cleared by the FDA?
Allergenetics Fluoro-Fast Reader (K831870) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 63 days after the submission was received.
What is the product code of K831870?
The FDA product code is JZT – Fluorometer, a Class I (low risk) device regulated under 21 CFR 866.4520.