ISOSCAN
FDA 510(k) clearance K944185 · decided 1994-11-17
Clearance details
- K-number
- K944185
- Device name
- ISOSCAN
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-26
- Decision date
- 1994-11-17
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- JQT
- Device class
- 1
- Regulation number
- 862.2400
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Akron, OH, 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 |
|---|---|---|
| ASIMANAGER - AT (K111356) | Arlington Scientific, Inc. | 2011-11-09 |
| MODEL 795 FLUOROMETER/DENSITOMETER (K915332) | Ciba Corning Diagnostics Corp. | 1992-02-18 |
| TARGET READER (K885254) | V-Tech, Inc. | 1989-01-27 |
| ELECTROPHORESIS DATA CENTER (EDC) (K860645) | Helena Laboratories | 1986-12-17 |
| ICON READER (K862956) | Hybritech, Inc. | 1986-08-19 |
| APOLLO DENSITOMETER (K853734) | Astral Medical Systems | 1985-09-25 |
| ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (K851154) | Astral Medical Systems | 1985-05-13 |
| CORNING 780 FLUOROMETER/DENSITOMETER (K850617) | Corning Medical & Scientific | 1985-03-12 |
| GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER (K850260) | Gelman Sciences, Inc. | 1985-02-27 |
| ELVI 146 SEROSCAN (K842313) | Logos Scientific, Inc. | 1984-09-10 |
| ELVI 165 PROTEO SEROSKOP (K842056) | Logos Scientific, Inc. | 1984-06-22 |
| 710 FLUOROMETER/DENSITOMETER (K810619) | Corning Medical & Scientific | 1981-03-27 |
Recalls involving this device
No recalls on record reference this clearance.