The following data is part of a premarket notification filed by Techhnilab Instruments, Inc. with the FDA for Disc-pak Rotator.
| Device ID | K780544 |
| 510k Number | K780544 |
| Device Name: | DISC-PAK ROTATOR |
| Classification | Mixer, Blood Tube |
| Applicant | TECHHNILAB INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GLE |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-03 |
| Decision Date | 1978-04-24 |