The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Ace Ii (tri-level).
| Device ID | K863095 |
| 510k Number | K863095 |
| Device Name: | ACE II (TRI-LEVEL) |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-13 |
| Decision Date | 1986-09-26 |