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 |