The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Endocrine Control, Levels 1 And 2.
| Device ID | K933317 |
| 510k Number | K933317 |
| Device Name: | LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Teva C Rothwell |
| Correspondent | Teva C Rothwell BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1993-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002079 | K933317 | 000 |
| 00847661000976 | K933317 | 000 |