FDA Product Code
FDA Product Code JZT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.4520
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962499 | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER | Bartels, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K883349 | QLIA IMMUNOCHEMISTRY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-09-07 | Traditional | PDF ↗ |
| K882677 | STAT-20 FLUOROMETER | Weaver Medical | 1988-07-12 | Traditional | PDF ↗ |
| K864699 | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | Pandex Laboratories, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K863434 | THE FIAX 5000 FLUOROMETER | Whittaker Bioproducts, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | Hybritech, Inc. | 1986-08-15 | Traditional | PDF ↗ |
| K852240 | SMS, SCREEN MACHINE SYSTEM | Pandex Laboratories, Inc. | 1985-06-11 | Traditional | PDF ↗ |
| K842049 | FLUOROSKAN | Flow Laboratories, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K843356 | FIAX 100 FLUOROMETER | Intl. Diagnostic Technology | 1984-09-17 | Traditional | PDF ↗ |
| K834070 | IMMPULSE SYSTEM | Paragon Diagnostics, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K831870 | ALLERGENETICS FLUORO-FAST READER | Axonics, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K800698 | AUTOFLUOR SYSTEM | California Immuno Diagnostic, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K782150 | FLUROMETER, DADE | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 | Traditional | PDF ↗ |
| K770662 | VIEWER, FLUOROMETIC, MODEL 721 | Corning Medical & Scientific | 1977-04-15 | Traditional | PDF ↗ |
Product code JZT · Class I · Immunology. Data: openFDA.