The following data is part of a premarket notification filed by Bio-rad, Diagnostics Grp. with the FDA for Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant Mcc.
| Device ID | K072721 |
| 510k Number | K072721 |
| Device Name: | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-26 |
| Decision Date | 2007-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005636 | K072721 | 000 |
| 00847661003342 | K072721 | 000 |
| 00847661003335 | K072721 | 000 |
| 00847661003328 | K072721 | 000 |
| 00847661003311 | K072721 | 000 |
| 00847661003304 | K072721 | 000 |