The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Chemistry Control/standard.
Device ID | K821382 |
510k Number | K821382 |
Device Name: | CHEMISTRY CONTROL/STANDARD |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-10 |
Decision Date | 1982-05-28 |