ULTRACHEM GLUC-DH, ITEM NO. 65048— 510(k) K811202
Substantially EquivalentHarleco
FDA 510(k) clearance K811202 for ULTRACHEM GLUC-DH, ITEM NO. 65048, Substantially Equivalent on 1981-05-27. Applicant: Harleco. Device class: 2.
Clearance details
- Applicant
- Harleco
- 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
Recent devices under product code LFR
view all- K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System
- K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM
- K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
- K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
- K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
More clearances from Harleco
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.