The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Creatinine (rate) Reagent Set.
Device ID | K905619 |
510k Number | K905619 |
Device Name: | CREATININE (RATE) REAGENT SET |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
Applicant | BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Contact | Alejo Roy |
Correspondent | Alejo Roy BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Product Code | CGX |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-14 |
Decision Date | 1991-02-13 |