The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Tri-point Brand Liquimmune Immunoassay Contr 1,2 & 3.
| Device ID | K934056 |
| 510k Number | K934056 |
| Device Name: | TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-19 |
| Decision Date | 1993-10-18 |