The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Reagent Tests Strip Combinations.
| Device ID | K833521 |
| 510k Number | K833521 |
| Device Name: | REAGENT TESTS STRIP COMBINATIONS |
| Classification | Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) |
| Applicant | SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJB |
| CFR Regulation Number | 862.1115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-11 |
| Decision Date | 1984-01-11 |