The following data is part of a premarket notification filed by Bioscan Instruments, Inc. with the FDA for Bioscan Reagent Strips.
| Device ID | K940043 |
| 510k Number | K940043 |
| Device Name: | BIOSCAN REAGENT STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | BIOSCAN INSTRUMENTS, INC. 39 WEST 32ND ST., RM. 303 New York, NY 10001 |
| Contact | Paul U Ju |
| Correspondent | Paul U Ju BIOSCAN INSTRUMENTS, INC. 39 WEST 32ND ST., RM. 303 New York, NY 10001 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-05 |
| Decision Date | 1994-04-12 |