The following data is part of a premarket notification filed by Ind Diagnostic Inc. with the FDA for Urine Chemistry Analyzer Ur-50.
| Device ID | K063390 |
| 510k Number | K063390 |
| Device Name: | URINE CHEMISTRY ANALYZER UR-50 |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | IND DIAGNOSTIC INC. P.O. BOX 162 Altamonte Springs, FL 32716 |
| Contact | Brian Lemay |
| Correspondent | Raylene Balard CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-03-01 |