The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Uropaper Eiken 6b.
Device ID | K843755 |
510k Number | K843755 |
Device Name: | UROPAPER EIKEN 6B |
Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
Applicant | SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Iwao Matsuoka |
Correspondent | Iwao Matsuoka SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
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 |