The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-ura Toxic Urine Control.
Device ID | K834259 |
510k Number | K834259 |
Device Name: | LIQUI-URA TOXIC URINE CONTROL |
Classification | Drug Mixture Control Materials |
Applicant | BIO DIAGNOSTIC INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-07 |
Decision Date | 1984-01-30 |