The following data is part of a premarket notification filed by More Diagnostics with the FDA for Cardiac Markers Control (single Use)-levels, 1,2,3, Models Number 175-1, 175-2, 175-3.
| Device ID | K982845 |
| 510k Number | K982845 |
| Device Name: | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | MORE DIAGNOSTICS 2020 11TH ST. Los Osos, CA 93402 |
| Contact | James W Snipes |
| Correspondent | James W Snipes MORE DIAGNOSTICS 2020 11TH ST. Los Osos, CA 93402 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-12 |
| Decision Date | 1998-08-21 |