ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID— 510(k) K860726
Substantially EquivalentTrace Scientific , Ltd.
FDA 510(k) clearance K860726 for ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID, Substantially Equivalent on 1986-04-21. Applicant: Trace Scientific , Ltd.. Device class: 2.
Clearance details
- Applicant
- Trace Scientific , Ltd.
- Product code
- Code LFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clayton, Vic 3168, AU
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More clearances from Trace Scientific , Ltd.
view allAdverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.