The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Chloride Cat. # 152-17.
Device ID | K875208 |
510k Number | K875208 |
Device Name: | CHLORIDE CAT. # 152-17 |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
Contact | Karen Callbeck |
Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-18 |
Decision Date | 1988-04-18 |