HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER— 510(k) K911141
Substantially EquivalentHemocue, Inc.
FDA 510(k) clearance K911141 for HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER, Substantially Equivalent on 1991-05-08. Applicant: Hemocue, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemocue, Inc.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Potomac, MD, US
Recent devices under product code CGA
view allMore clearances from Hemocue, Inc.
view allAdverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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 →
Recalls naming K911141
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911141.
Data sourced from openFDA. This site is unofficial and independent of the FDA.