The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Liquid Urinalysis Control.
Device ID | K954323 |
510k Number | K954323 |
Device Name: | MAS LIQUID URINALYSIS CONTROL |
Classification | Multi-analyte Controls, All Kinds (assayed) |
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 | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-15 |
Decision Date | 1995-11-09 |