COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN— 510(k) K900377
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K900377 for COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN, Substantially Equivalent on 1990-03-06. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.