Fluoroskan
FDA 510(k) K842049 · Flow Laboratories, Inc.
510(k) numberK842049
Submission
- Device name
- Fluoroskan
- Applicant
- Flow Laboratories, Inc.
Mclean, VA, US - Received
- May 22, 1984
- Decision date
- December 3, 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 |
| K843356 | Fiax 100 FluorometerJZT · Traditional | Intl. Diagnostic Technology | 09/17/1984SE |
| K834070 | Immpulse SystemJZT · Traditional | Paragon Diagnostics, Inc. | 03/23/1984SE |
| K831870 | Allergenetics Fluoro-Fast ReaderJZT · Traditional | Axonics, Inc. | 08/12/1983SE |
More from Axonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Fluoroskan cleared by the FDA?
Fluoroskan (K842049) received a 510(k) decision of Substantially Equivalent on December 3, 1984, 195 days after the submission was received.
What is the product code of K842049?
The FDA product code is JZT – Fluorometer, a Class I (low risk) device regulated under 21 CFR 866.4520.