The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Triglyzyme V Eiken.
Device ID | K821106 |
510k Number | K821106 |
Device Name: | TRIGLYZYME V EIKEN |
Classification | Colorimetric Method, Triglycerides |
Applicant | SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JGY |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-20 |
Decision Date | 1982-05-05 |