Flurometer, Dade
FDA 510(k) K782150 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK782150
Submission
- Device name
- Flurometer, Dade
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- December 26, 1978
- Decision date
- February 15, 1979
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
Questions and answers
When was Flurometer, Dade cleared by the FDA?
Flurometer, Dade (K782150) received a 510(k) decision of Substantially Equivalent on February 15, 1979, 51 days after the submission was received.
What is the product code of K782150?
The FDA product code is JZT – Fluorometer, a Class I (low risk) device regulated under 21 CFR 866.4520.