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.
| Device ID | K954322 |
| 510k Number | K954322 |
| Device Name: | TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1995-10-11 |