VISION BG TEST STRIP— 510(k) K911624
Substantially EquivalentBritish-American Medical, Inc.
FDA 510(k) clearance K911624 for VISION BG TEST STRIP, Substantially Equivalent on 1991-07-17. Applicant: British-American Medical, Inc..
Clearance details
- Applicant
- British-American Medical, Inc.
- Product code
- Code CGA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Hills, CA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.