The following data is part of a premarket notification filed by Lee Import Domestic Consulting with the FDA for Charise Charles Reagent Strips.
| Device ID | K895282 |
| 510k Number | K895282 |
| Device Name: | CHARISE CHARLES REAGENT STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | LEE IMPORT DOMESTIC CONSULTING 3049 GREENMOUNT RD. Orlando, FL 32806 |
| Contact | Lavar R Lee |
| Correspondent | Lavar R Lee LEE IMPORT DOMESTIC CONSULTING 3049 GREENMOUNT RD. Orlando, FL 32806 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-24 |
| Decision Date | 1990-01-10 |