The following data is part of a premarket notification filed by Cortex Research Corp. with the FDA for Cortex Double Helix Sampler.
| Device ID | K800003 |
| 510k Number | K800003 |
| Device Name: | CORTEX DOUBLE HELIX SAMPLER |
| Classification | Mixer, Blood Tube |
| Applicant | CORTEX RESEARCH CORP. 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 | 1980-01-02 |
| Decision Date | 1980-02-01 |