The following data is part of a premarket notification filed by More Diagnostics with the FDA for Whole Blood Volatiles Control, Levels 1 And 2.
| Device ID | K941876 |
| 510k Number | K941876 |
| Device Name: | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MORE DIAGNOSTICS 2216 SUNSET DR. Los Osos, CA 93402 |
| Contact | James Snipes |
| Correspondent | James Snipes MORE DIAGNOSTICS 2216 SUNSET DR. Los Osos, CA 93402 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-18 |
| Decision Date | 1994-07-28 |