The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Tri-point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, And 3.
| Device ID | K993546 |
| 510k Number | K993546 |
| Device Name: | TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Scot Kinghorn |
| Correspondent | Scot Kinghorn MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-19 |
| Decision Date | 1999-11-30 |