DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
FDA 510(k) clearance K851636 · decided 1985-07-30
Clearance details
- K-number
- K851636
- Device name
- DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1985-04-19
- Decision date
- 1985-07-30
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Richmond, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |