The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Fertility Control, Models 480, 481, 482, 483.
| Device ID | K002196 |
| 510k Number | K002196 |
| Device Name: | LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2000-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001829 | K002196 | 000 |
| 00847661001010 | K002196 | 000 |
| 00847661001003 | K002196 | 000 |
| 00847661000990 | K002196 | 000 |
| 00847661000983 | K002196 | 000 |