ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
FDA 510(k) clearance K990282 · decided 1999-03-09
Clearance details
- K-number
- K990282
- Device name
- ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1999-01-29
- Decision date
- 1999-03-09
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bio-Rad
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |