The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Uropaper Eiken Gk.
Device ID | K843758 |
510k Number | K843758 |
Device Name: | UROPAPER EIKEN GK |
Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
Applicant | SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Contact | Iwao Matsuoka |
Correspondent | Iwao Matsuoka SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JIL |
CFR Regulation Number | 862.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-25 |
Decision Date | 1984-12-18 |