The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Inorganic Phosphorus.
Device ID | K874472 |
510k Number | K874472 |
Device Name: | INORGANIC PHOSPHORUS |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
Contact | Luis P Leon |
Correspondent | Luis P Leon CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-02 |
Decision Date | 1987-12-22 |