The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Directdraw Superserum-mini.
| Device ID | K935081 |
| 510k Number | K935081 |
| Device Name: | DIRECTDRAW SUPERSERUM-MINI |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-01-11 |