The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Chloride For Continuous Flow Instruments.
Device ID | K872511 |
510k Number | K872511 |
Device Name: | CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
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 | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-24 |
Decision Date | 1987-07-21 |