The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Urine Total Protein Control.
| Device ID | K831526 |
| 510k Number | K831526 |
| Device Name: | URINE TOTAL PROTEIN CONTROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-12 |
| Decision Date | 1983-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400829 | K831526 | 000 |
| 00811727011930 | K831526 | 000 |
| 00811727011909 | K831526 | 000 |