The following data is part of a premarket notification filed by More Diagnostics with the FDA for Lead Control (whole Blood) Levels 1,2,3,4.
| Device ID | K970778 |
| 510k Number | K970778 |
| Device Name: | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MORE DIAGNOSTICS 2216 SUNSET DR. Los Osos, CA 93402 |
| Contact | James W Snipes |
| Correspondent | James W Snipes MORE DIAGNOSTICS 2216 SUNSET DR. Los Osos, CA 93402 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-04-17 |