JZT
14 FDA 510(k) clearances · Product code
51 daysmedian time to decision
119 days90th percentile
14clearances measured
FDA profile
- Official device name
- Fluorometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4520
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 2001: 14 · 2005: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (K962499) | Bartels, Inc. | 1996-09-05 |
| QLIA IMMUNOCHEMISTRY SYSTEM (K883349) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-09-07 |
| STAT-20 FLUOROMETER (K882677) | Weaver Medical | 1988-07-12 |
| FLUORESCENCE CONCENTRATION ANALYZER (FCA) (K864699) | Pandex Laboratories, Inc. | 1986-12-22 |
| THE FIAX 5000 FLUOROMETER (K863434) | Whittaker Bioproducts, Inc. | 1986-10-29 |
| PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM (K862674) | Hybritech, Inc. | 1986-08-15 |
| SMS, SCREEN MACHINE SYSTEM (K852240) | Pandex Laboratories, Inc. | 1985-06-11 |
| FLUOROSKAN (K842049) | Flow Laboratories, Inc. | 1984-12-03 |
| FIAX 100 FLUOROMETER (K843356) | Intl. Diagnostic Technology | 1984-09-17 |
| IMMPULSE SYSTEM (K834070) | Paragon Diagnostics, Inc. | 1984-03-23 |
| ALLERGENETICS FLUORO-FAST READER (K831870) | Axonics, Inc. | 1983-08-12 |
| AUTOFLUOR SYSTEM (K800698) | California Immuno Diagnostic, Inc. | 1980-05-28 |
| FLUROMETER, DADE (K782150) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 |
| VIEWER, FLUOROMETIC, MODEL 721 (K770662) | Corning Medical & Scientific | 1977-04-15 |
Track JZT automatically
Every clearance here is in the API, with alerts when new ones post.