The following data is part of a premarket notification filed by Spectral Medical Inc. with the FDA for Endotoxin Activity Assay (eaa).
| Device ID | K183176 |
| 510k Number | K183176 |
| Device Name: | Endotoxin Activity Assay (EAA) |
| Classification | Assay, Endotoxin Activity, Chemiluminescent |
| Applicant | Spectral Medical Inc. 135 The West Mall, Unit 2 Toronto, CA M9c 1c2 |
| Contact | Danijela Domljanovic |
| Correspondent | Danijela Domljanovic Spectral Medical Inc. 135 The West Mall, Unit 2 Toronto, CA M9c 1c2 |
| Product Code | NGS |
| CFR Regulation Number | 866.3210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-03-12 |