The following data is part of a premarket notification filed by Genesis Labs, Inc. with the FDA for Bioscan Reagent Strips.
| Device ID | K943008 |
| 510k Number | K943008 |
| Device Name: | BIOSCAN REAGENT STRIPS |
| Classification | Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) |
| Applicant | GENESIS LABS, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Martha Cornell |
| Correspondent | Martha Cornell GENESIS LABS, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | JJB |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JMT |
| CFR Regulation Number | 862.1115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-24 |
| Decision Date | 1994-08-08 |