ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
FDA 510(k) clearance K984324 · decided 1998-12-15
Clearance details
- K-number
- K984324
- Device name
- ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1998-12-03
- Decision date
- 1998-12-15
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- JJX
- 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bot recall (Z-1222-2007) | Abbott Laboratories | 2007-09-18 |
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 |