HEMOCHRON JR. SIGNATURE +— 510(k) K020798
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K020798 for HEMOCHRON JR. SIGNATURE +, Substantially Equivalent on 2002-03-28. 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
- Special
- Location
- Edison, NJ, US
Recent devices under product code JPA
view allMore clearances from International Technidyne Corp.
view all- K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
- K050016 — HEMOCHRON SIGNATURE ELITE
- K030818 — HEMOCHRON RESPONSE/SYSTEM
- K023561 — ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
- K010599 — PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
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.