HEMOSIL PT-FIBRINOGEN HS PLUS— 510(k) K060931
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K060931 for HEMOSIL PT-FIBRINOGEN HS PLUS, Substantially Equivalent on 2006-05-02. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GJS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Recent devices under product code GJS
view allMore clearances from Instrumentation Laboratory CO
view allAdverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
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 →
Recalls naming K060931
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060931.
Data sourced from openFDA. This site is unofficial and independent of the FDA.