The following data is part of a premarket notification filed by Macherey-nagel Gmbh & Co., Kg. with the FDA for Uryxxon Relax Urine Analyzer.
| Device ID | K061742 |
| 510k Number | K061742 |
| Device Name: | URYXXON RELAX URINE ANALYZER |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | MACHEREY-NAGEL GMBH & CO., KG. 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 |
| Contact | Armond Welch |
| Correspondent | Armond Welch MACHEREY-NAGEL GMBH & CO., KG. 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIP |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | KQO |
| Subsequent Product Code | KSL |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763924897104 | K061742 | 000 |
| 10763924850508 | K061742 | 000 |