The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Therapeutic Drug Monitoring Control.
| Device ID | K880145 |
| 510k Number | K880145 |
| Device Name: | LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Frank Matarrese |
| Correspondent | Frank Matarrese BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001812 | K880145 | 000 |
| 00847661001409 | K880145 | 000 |
| 00847661001393 | K880145 | 000 |
| 00847661001386 | K880145 | 000 |
| 00847661001379 | K880145 | 000 |