The following data is part of a premarket notification filed by More Diagnostics with the FDA for Rap/tac/csa Control - Level 1,2,3,4.
| Device ID | K050125 |
| 510k Number | K050125 |
| Device Name: | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-19 |
| Decision Date | 2005-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856743007239 | K050125 | 000 |
| 00856743007130 | K050125 | 000 |
| 00856743007147 | K050125 | 000 |
| 00856743007154 | K050125 | 000 |
| 00856743007161 | K050125 | 000 |
| 00856743007178 | K050125 | 000 |
| 00856743007185 | K050125 | 000 |
| 00856743007192 | K050125 | 000 |
| 00856743007208 | K050125 | 000 |
| 00856743007215 | K050125 | 000 |
| 00856743007222 | K050125 | 000 |
| 00856743007123 | K050125 | 000 |