The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Creatinine Standard Solution Calibrator.
Device ID | K871756 |
510k Number | K871756 |
Device Name: | CREATININE STANDARD SOLUTION CALIBRATOR |
Classification | Calibrator, Secondary |
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 | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-05 |
Decision Date | 1987-05-27 |