The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Urine Chloride.
Device ID | K923036 |
510k Number | K923036 |
Device Name: | URINE CHLORIDE |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Robert L Habig |
Correspondent | Robert L Habig HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-19 |
Decision Date | 1992-09-09 |