The following data is part of a premarket notification filed by Medical Specialties Laboratories with the FDA for Normlcera.
| Device ID | K810268 |
| 510k Number | K810268 |
| Device Name: | NORMLCERA |
| Classification | Sera, Animal And Human |
| Applicant | MEDICAL SPECIALTIES LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIS |
| CFR Regulation Number | 864.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-02 |
| Decision Date | 1981-03-06 |