The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako(tm) Autokit Cholesterol.
Device ID | K880311 |
510k Number | K880311 |
Device Name: | WAKO(TM) AUTOKIT CHOLESTEROL |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
Contact | Toshihiko Oda |
Correspondent | Toshihiko Oda WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-25 |
Decision Date | 1988-03-01 |