JZT — Fluorometer Class I
FDA product code JZT covers "Fluorometer", a Class I medical device regulated under 21 CFR 866.4520. Submissions are reviewed by the Immunology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JZT
- Device Class
- Class I
- Regulation Number
- 866.4520
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962499 | bartels | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER | September 5, 1996 |
| K883349 | bd becton dickinson vacutainer systems preanalytic | QLIA IMMUNOCHEMISTRY SYSTEM | September 7, 1988 |
| K882677 | weaver medical | STAT-20 FLUOROMETER | July 12, 1988 |
| K864699 | pandex laboratories | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | December 22, 1986 |
| K863434 | whittaker bioproducts | THE FIAX 5000 FLUOROMETER | October 29, 1986 |
| K862674 | hybritech | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | August 15, 1986 |
| K852240 | pandex laboratories | SMS, SCREEN MACHINE SYSTEM | June 11, 1985 |
| K842049 | flow laboratories | FLUOROSKAN | December 3, 1984 |
| K843356 | intl. diagnostic technology | FIAX 100 FLUOROMETER | September 17, 1984 |
| K834070 | paragon diagnostics | IMMPULSE SYSTEM | March 23, 1984 |
| K831870 | axonics | ALLERGENETICS FLUORO-FAST READER | August 12, 1983 |
| K800698 | california immuno diagnostic | AUTOFLUOR SYSTEM | May 28, 1980 |
| K782150 | dade, baxter travenol diagnostics | FLUROMETER, DADE | February 15, 1979 |
| K770662 | corning medical and scientific | VIEWER, FLUOROMETIC, MODEL 721 | April 15, 1977 |