The following data is part of a premarket notification filed by Actio, Inc. with the FDA for Shape-actio Urinalysis Controls.
| Device ID | K890442 |
| 510k Number | K890442 |
| Device Name: | SHAPE-ACTIO URINALYSIS CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ACTIO, INC. 1127-57TH AVE. Oakland, CA 94621 |
| Contact | Nathan Lewin |
| Correspondent | Nathan Lewin ACTIO, INC. 1127-57TH AVE. Oakland, CA 94621 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-03-08 |