The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Benzo/tca Control Serum, Levels 1 And 2.
| Device ID | K910829 |
| 510k Number | K910829 |
| Device Name: | LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 |
| Classification | Drug Specific Control Materials |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Sharon K Smith |
| Correspondent | Sharon K Smith BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-27 |
| Decision Date | 1991-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002130 | K910829 | 000 |
| 00847661000587 | K910829 | 000 |
| 00847661000570 | K910829 | 000 |