Immpulse System
FDA 510(k) K834070 · Paragon Diagnostics, Inc.
510(k) numberK834070
Submission
- Device name
- Immpulse System
- Applicant
- Paragon Diagnostics, Inc.
Mchenry, IL, US - Received
- November 25, 1983
- Decision date
- March 23, 1984
- 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 |
| K831870 | Allergenetics Fluoro-Fast ReaderJZT · Traditional | Axonics, Inc. | 08/12/1983SE |
More from Axonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841162 | Immpulse Gentamicin Assay ReagentsLCQ · Traditional | 05/02/1984SE |
| K841161 | Immpulse Amikacin Assay ReagentsKLQ · Traditional | 05/02/1984SE |
| K840852 | Immpulse T4 Assay ReagentsCDX · Traditional | 04/18/1984SE |
| K840847 | Immpulse Tobramycin Assay ReagentsLCR · Traditional | 04/04/1984SE |
| K840758 | Immpulse Theophylline Assay ReagentsLER · Traditional | 04/04/1984SE |
| K840853 | Immpulse TBC Assay ReagentsKHQ · Traditional | 04/01/1984SE |
Questions and answers
When was Immpulse System cleared by the FDA?
Immpulse System (K834070) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 119 days after the submission was received.
What is the product code of K834070?
The FDA product code is JZT – Fluorometer, a Class I (low risk) device regulated under 21 CFR 866.4520.