The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako(tm) Autokit Lipase.
Device ID | K874640 |
510k Number | K874640 |
Device Name: | WAKO(TM) AUTOKIT LIPASE |
Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
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 | CHI |
CFR Regulation Number | 862.1465 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-12 |
Decision Date | 1987-12-22 |