K940401 is an FDA 510(k) clearance for the JR. MICROCOAGULATION SYSTEM. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on May 11, 1994, 104 days after receiving the submission on January 27, 1994.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K940401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1994 |
| Decision Date | May 11, 1994 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JPA — System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5425 |