FLUOROSKAN
FDA 510(k) clearance K842049 · decided 1984-12-03
Clearance details
- K-number
- K842049
- Device name
- FLUOROSKAN
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-22
- Decision date
- 1984-12-03
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- JZT
- Device class
- 1
- Regulation number
- 866.4520
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mclean, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 3M BRAND MICROBIAL PROFILE SYSTEM (N50538/S001) | Flow Laboratories, Inc. | 1981-04-17 |
| FLOW MIC SYSTEM (N50538) | Flow Laboratories, Inc. | 1980-07-15 |