ULTRACHEM GLUC-DH— 510(k) K821867
Substantially EquivalentHarleco Diagnostics
FDA 510(k) clearance K821867 for ULTRACHEM GLUC-DH, Substantially Equivalent on 1982-07-06. Applicant: Harleco Diagnostics. Device class: 2.
Clearance details
- Applicant
- Harleco Diagnostics
- 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
- Mchenry, IL, US
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More clearances from Harleco Diagnostics
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.