510(k) K940401 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
JR. MICROCOAGULATION SYSTEM
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, May 11, 1994 |
| Received | Jan 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Accriva Diagnostics, Inc. Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103 Open, Classified |
JPA | None listed |
| Apr 22, 2016 | Accriva Diagnostics Inc., dba ITC, dba Accumetrics Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. Terminated |
JPA | None listed |
| Jul 21, 2014 | ITC-Nexus Dx Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103. Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.