The following data is part of a premarket notification filed by Lee Import Domestic Consulting with the FDA for Charise Charles Reagent Blood Strips.
| Device ID | K893894 |
| 510k Number | K893894 |
| Device Name: | CHARISE CHARLES REAGENT BLOOD STRIPS |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | LEE IMPORT DOMESTIC CONSULTING 3049 GREENMOUNT RD. Orlando, FL 32806 |
| Contact | Lavar Lee |
| Correspondent | Lavar Lee LEE IMPORT DOMESTIC CONSULTING 3049 GREENMOUNT RD. Orlando, FL 32806 |
| Product Code | JIO |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-07-27 |