ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025— 510(k) K981512
Substantially EquivalentSkd, Inc. A Beckman Coulter Co.
FDA 510(k) clearance K981512 for ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025, Substantially Equivalent on 1998-05-28. Applicant: Skd, Inc. A Beckman Coulter Co.. Device class: 2.
Clearance details
- Applicant
- Skd, Inc. A Beckman Coulter Co.
- Product code
- Code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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.