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 |