The following data is part of a premarket notification filed by More Diagnostics with the FDA for Immunosuppressant (whole Blood) Control, Level 1 250-1, Immunosuppressant (whole Bloos) Control, Level 2, 250-2, Immun\s.
| Device ID | K980331 |
| 510k Number | K980331 |
| Device Name: | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S |
| Classification | Drug Mixture Control Materials |
| 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 | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-28 |
| Decision Date | 1998-03-16 |