STRATUS IINTELLECT IMMUNOASSAY SYSTEM— 510(k) K913130
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K913130 for STRATUS IINTELLECT IMMUNOASSAY SYSTEM, Substantially Equivalent on 1991-09-27. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code KHO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2560
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code KHO
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Adverse events under product code KHO
product code KHO- Malfunction
- 1,339
- Total
- 1,339
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.