AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
FDA 510(k) clearance K952720 · decided 1995-09-20
Clearance details
- K-number
- K952720
- Device name
- AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
- Applicant
- Aalto Scientific, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-15
- Decision date
- 1995-09-20
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- JPK
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hem recall (Z-0349-2023) | Primus Corporation dba Trinity Biotech | 2022-12-01 |
| Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part numb recall (Z-0350-2023) | Primus Corporation dba Trinity Biotech | 2022-12-01 |
| Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distri recall (Z-0131-06) | Tosoh Bioscience, Inc. | 2005-11-15 |