LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
FDA 510(k) clearance K891691 · decided 1989-12-19
Clearance details
- K-number
- K891691
- Device name
- LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1989-03-22
- Decision date
- 1989-12-19
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- DIE
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hercules, CA, 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 |
|---|---|---|
| LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610) | Bio-Rad | 2002-04-22 |
| LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (K990928) | Bio-Rad | 1999-04-16 |
| SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K890721) | Actio, Inc. | 1989-04-10 |
| SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K863915) | Shape Products Co. | 1986-11-24 |
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 |