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 |