The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Challenge Brand Liquid Multi-enzyme Linearity Cont.
Device ID | K903225 |
510k Number | K903225 |
Device Name: | CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Contact | Donna L Anderson |
Correspondent | Donna L Anderson 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 | 1990-07-23 |
Decision Date | 1990-08-17 |