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 | K935062 |
510k Number | K935062 |
Device Name: | MAS LIQUID URINALYSIS CONTROL |
Classification | Urinalysis Controls (assayed And Unassayed) |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Contact | Patricia V Willis |
Correspondent | Patricia V Willis MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Product Code | JJW |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-20 |
Decision Date | 1994-01-27 |