Product code JZT
- Device name
- Fluorometer
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.4520
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962499 | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER | Bartels, Inc. | 1996-09-05 |
| K883349 | QLIA IMMUNOCHEMISTRY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-09-07 |
| K882677 | STAT-20 FLUOROMETER | Weaver Medical | 1988-07-12 |
| K864699 | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | Pandex Laboratories, Inc. | 1986-12-22 |
| K863434 | THE FIAX 5000 FLUOROMETER | Whittaker Bioproducts, Inc. | 1986-10-29 |
| K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | Hybritech, Inc. | 1986-08-15 |
| K852240 | SMS, SCREEN MACHINE SYSTEM | Pandex Laboratories, Inc. | 1985-06-11 |
| K842049 | FLUOROSKAN | Flow Laboratories, Inc. | 1984-12-03 |
| K843356 | FIAX 100 FLUOROMETER | Intl. Diagnostic Technology | 1984-09-17 |
| K834070 | IMMPULSE SYSTEM | Paragon Diagnostics, Inc. | 1984-03-23 |
| K831870 | ALLERGENETICS FLUORO-FAST READER | Axonics, Inc. | 1983-08-12 |
| K800698 | AUTOFLUOR SYSTEM | California Immuno Diagnostic, Inc. | 1980-05-28 |
| K782150 | FLUROMETER, DADE | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 |
| K770662 | VIEWER, FLUOROMETIC, MODEL 721 | Corning Medical & Scientific | 1977-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800026300083 | Exdia TRF Plus | Precision Biosensor Inc. | 2022-11-16 |
| 04260157633216 | B.R.A.H.M.S KRYPTOR compact SOLUTION 1 | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157633223 | B.R.A.H.M.S KRYPTOR compact SOLUTION 2 | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157633230 | B.R.A.H.M.S KRYPTOR compact SOLUTION 3 | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157633247 | B.R.A.H.M.S KRYPTOR compact SOLUTION 4 | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157638976 | B.R.A.H.M.S KRYPTOR compact REACT | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157638983 | B.R.A.H.M.S KRYPTOR compact DILCUP | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157638990 | B.R.A.H.M.S KRYPTOR BUFFER | B.R.A.H.M.S GmbH | 2016-08-17 |
| 04260157630949 | B.R.A.H.M.S KRYPTOR compact PLUS | B.R.A.H.M.S GmbH | 2016-08-17 |