JR. MICROCOAGULATION SYSTEM— 510(k) K940401
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K940401 for JR. MICROCOAGULATION SYSTEM, Substantially Equivalent on 1994-05-11. Applicant: International Technidyne Corp.. Device class: 2.
Clearance details
- Applicant
- International Technidyne 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
- Edison, NJ, US
Recent devices under product code JPA
view allMore clearances from International Technidyne Corp.
view allAdverse 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 →
Recalls naming K940401
K-number listed on FDA's recall record- Z-1720-2016 — Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
- Z-2088-2014 — Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K940401.
Data sourced from openFDA. This site is unofficial and independent of the FDA.