The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Quantitative Urine Control Abnormal (2).
| Device ID | K880495 |
| 510k Number | K880495 |
| Device Name: | LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Frank Matarrese |
| Correspondent | Frank Matarrese BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-04 |
| Decision Date | 1988-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002000 | K880495 | 000 |
| 00847661001485 | K880495 | 000 |