The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Immunoassay Plus Control.
| Device ID | K981532 |
| 510k Number | K981532 |
| Device Name: | LYPHOCHEK IMMUNOASSAY PLUS CONTROL |
| 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 | 1998-04-29 |
| Decision Date | 1998-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001805 | K981532 | 000 |
| 00847661001102 | K981532 | 000 |
| 00847661001096 | K981532 | 000 |
| 00847661001089 | K981532 | 000 |
| 00847661001072 | K981532 | 000 |