The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Uropaper Eiken 8.
Device ID | K843532 |
510k Number | K843532 |
Device Name: | UROPAPER EIKEN 8 |
Classification | Reagent, Occult Blood |
Applicant | SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
Contact | Iwao Matsuoka |
Correspondent | Iwao Matsuoka SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
Product Code | KHE |
CFR Regulation Number | 864.6550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-07 |
Decision Date | 1984-12-12 |