The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Jr. Microcoagulation System.
| Device ID | K940401 |
| 510k Number | K940401 |
| Device Name: | JR. MICROCOAGULATION SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Robert N Borghese |
| Correspondent | Robert N Borghese INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1994-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234103012 | K940401 | 000 |