The following data is part of a premarket notification filed by Pharmaseal Laboratories with the FDA for Sampling Kit.
| Device ID | K801146 |
| 510k Number | K801146 |
| Device Name: | SAMPLING KIT |
| Classification | Arterial Blood Sampling Kit |
| Applicant | PHARMASEAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-13 |
| Decision Date | 1980-06-04 |