The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Drug Free Serum(human).
| Device ID | K852414 |
| 510k Number | K852414 |
| Device Name: | LYPHOCHEK DRUG FREE SERUM(HUMAN) |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Tom Sandoval |
| Correspondent | Tom Sandoval BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-06 |
| Decision Date | 1985-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002055 | K852414 | 000 |
| 00847661000907 | K852414 | 000 |