The following data is part of a premarket notification filed by More Diagnostics with the FDA for Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-level.
| Device ID | K972976 |
| 510k Number | K972976 |
| Device Name: | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL |
| 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 | 1997-08-11 |
| Decision Date | 1997-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856743007048 | K972976 | 000 |
| 00856743007031 | K972976 | 000 |
| 00856743007024 | K972976 | 000 |
| 00856743007017 | K972976 | 000 |