The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Urisys 2400 Urine Test Strip.
| Device ID | K012397 |
| 510k Number | K012397 |
| Device Name: | URISYS 2400 URINE TEST STRIP |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-27 |
| Decision Date | 2001-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630004683 | K012397 | 000 |
| 04015630004652 | K012397 | 000 |