The following data is part of a premarket notification filed by Arden Medical Systems, Inc. with the FDA for A.qc Chemistry Control Level 2.
| Device ID | K883012 |
| 510k Number | K883012 |
| Device Name: | A.QC CHEMISTRY CONTROL LEVEL 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ARDEN MEDICAL SYSTEMS, INC. 2675 LONG LAKE RD. P.O. BOX 64302 Roseville, MN 55113 |
| Contact | Barbara E Roth |
| Correspondent | Barbara E Roth ARDEN MEDICAL SYSTEMS, INC. 2675 LONG LAKE RD. P.O. BOX 64302 Roseville, MN 55113 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-09-09 |