The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Directdraw Superserum.
| Device ID | K921778 |
| 510k Number | K921778 |
| Device Name: | DIRECTDRAW SUPERSERUM |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Matt Lesnieski |
| Correspondent | Matt Lesnieski INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1992-05-28 |