BIO-PEN SRK II CALCULATOR
FDA 510(k) clearance K922590 · decided 1993-08-03
Clearance details
- K-number
- K922590
- Device name
- BIO-PEN SRK II CALCULATOR
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1992-06-02
- Decision date
- 1993-08-03
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- LQB
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Glendale, 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 |
|---|---|---|
| BIO-PEN CALCULATOR (K860205) | Oculab, Inc. | 1986-04-24 |
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 |