The following data is part of a premarket notification filed by Actio, Inc. with the FDA for Shape-actio Urinalysis Controls(assayed & Unassay).
| Device ID | K902699 |
| 510k Number | K902699 |
| Device Name: | SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| 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 | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-07-16 |