The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Hypertension Markers Control (cat. No. 600).
| Device ID | K971952 |
| 510k Number | K971952 |
| Device Name: | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt 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 | 1997-05-28 |
| Decision Date | 1997-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001904 | K971952 | 000 |
| 00847661001065 | K971952 | 000 |