The following data is part of a premarket notification filed by Arden Medical Systems, Inc. with the FDA for Chempro 1000(tm).
| Device ID | K870860 |
| 510k Number | K870860 |
| Device Name: | CHEMPRO 1000(TM) |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | ARDEN MEDICAL SYSTEMS, INC. 3771 LEXINGTON AVE. N. Arden Hills, MN 55126 |
| Contact | Walter Sembrowich |
| Correspondent | Walter Sembrowich ARDEN MEDICAL SYSTEMS, INC. 3771 LEXINGTON AVE. N. Arden Hills, MN 55126 |
| Product Code | GKF |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-04-14 |