i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials— 510(k) K133002
Substantially EquivalentAbbott Point of Care, Inc.
FDA 510(k) clearance K133002 for i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials, Substantially Equivalent on 2015-04-16. Applicant: Abbott Point of Care, Inc..
Clearance details
- Applicant
- Abbott Point of Care, Inc.
- Product code
- Code DHA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princton, NJ, US
Adverse events under product code DHA
product code DHA- Malfunction
- 1,242
- Total
- 1,242
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.