The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-ura Chemistry Urine Controls.
| Device ID | K840618 |
| 510k Number | K840618 |
| Device Name: | LIQUI-URA CHEMISTRY URINE CONTROLS |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | BIO DIAGNOSTIC INTL. 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 | 1984-02-14 |
| Decision Date | 1984-04-04 |