The following data is part of a premarket notification filed by Actio, Inc. with the FDA for Assayed Cholinesterase Control.
| Device ID | K885282 |
| 510k Number | K885282 |
| Device Name: | ASSAYED CHOLINESTERASE CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ACTIO, INC. 1127-57TH AVE. Oakland, CA 94621 |
| Contact | Nathan Lewis |
| Correspondent | Nathan Lewis ACTIO, INC. 1127-57TH AVE. Oakland, CA 94621 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-20 |
| Decision Date | 1989-06-09 |