The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphocheck Urine Metals Control, Item No.400, 405.
| Device ID | K990928 |
| 510k Number | K990928 |
| Device Name: | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 |
| Classification | Heavy Metals Control Materials |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | DIE |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-19 |
| Decision Date | 1999-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004073 | K990928 | 000 |
| 00847661000297 | K990928 | 000 |
| 00847661000280 | K990928 | 000 |