The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Benzo/tca Control-set B.
| Device ID | K955153 |
| 510k Number | K955153 |
| Device Name: | LYPHOCHEK BENZO/TCA CONTROL-SET B |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Donna Chapman |
| Correspondent | Donna Chapman 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 | 1995-11-13 |
| Decision Date | 1996-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002147 | K955153 | 000 |
| 00847661000600 | K955153 | 000 |
| 00847661000594 | K955153 | 000 |