The following data is part of a premarket notification filed by Bioscan Instruments, Inc. with the FDA for Bioscan Urine Diagnostic Reagent Strips.
| Device ID | K875248 |
| 510k Number | K875248 |
| Device Name: | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS |
| Classification | Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Applicant | BIOSCAN INSTRUMENTS, INC. 39W 32ND ST. New York, NY 10001 |
| Contact | Paul U Ju |
| Correspondent | Paul U Ju BIOSCAN INSTRUMENTS, INC. 39W 32ND ST. New York, NY 10001 |
| Product Code | JMT |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-02-24 |