AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II— 510(k) K952720
Substantially EquivalentAalto Scientific, Ltd.
FDA 510(k) clearance K952720 for AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II, Substantially Equivalent on 1995-09-20. Applicant: Aalto Scientific, Ltd.. Device class: 2.
Clearance details
- Applicant
- Aalto Scientific, Ltd.
- Product code
- Code JPK
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vista, CA, US
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Recalls naming K952720
K-number listed on FDA's recall record- Z-0349-2023 — A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
- Z-0350-2023 — Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.