The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Urine Screening Kit.
| Device ID | K830824 |
| 510k Number | K830824 |
| Device Name: | URINE SCREENING KIT |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| Applicant | SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEN |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-15 |
| Decision Date | 1983-06-12 |