The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Kinetic Alkaline Phosphatase Determination.
Device ID | K905650 |
510k Number | K905650 |
Device Name: | KINETIC ALKALINE PHOSPHATASE DETERMINATION |
Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Contact | Alejo V Roy |
Correspondent | Alejo V Roy BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Product Code | CJE |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-18 |
Decision Date | 1991-02-13 |