The following data is part of a premarket notification filed by D.f.i. Co Ltd with the FDA for Cybow 11 Series Reagent Strips For Urinalysis.
| Device ID | K052525 |
| 510k Number | K052525 |
| Device Name: | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | D.F.I. CO LTD 2815 MCGAW AVENUE Irvine, CA 92614 |
| Contact | Asad R Zaidi |
| Correspondent | Asad R Zaidi D.F.I. CO LTD 2815 MCGAW AVENUE Irvine, CA 92614 |
| 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 | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2006-03-29 |