The following data is part of a premarket notification filed by More Diagnostics with the FDA for Cyclosporine (whole Blood) Control-pediatric Level.
| Device ID | K932662 |
| 510k Number | K932662 |
| Device Name: | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL |
| Classification | Drug Specific Control Materials |
| Applicant | MORE DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Contact | James W Snipes |
| Correspondent | James W Snipes MORE DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1993-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856743007055 | K932662 | 000 |