The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Hepa-shure -l.
| Device ID | K802120 |
| 510k Number | K802120 |
| Device Name: | HEPA-SHURE -L |
| Classification | Oncometer, Plasma, For Clinical Use |
| Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJK |
| CFR Regulation Number | 862.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-04 |
| Decision Date | 1980-10-20 |