The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Phosphorus (inorganic) Test System.
Device ID | K910296 |
510k Number | K910296 |
Device Name: | PHOSPHORUS (INORGANIC) TEST SYSTEM |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Contact | Roy, Ph.d. |
Correspondent | Roy, Ph.d. BIOCHEMICAL TRADE, INC. 7522 N.W. 55TH ST. Miami, FL 33166 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-23 |
Decision Date | 1991-02-27 |