The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Chloride Reagent.
Device ID | K863620 |
510k Number | K863620 |
Device Name: | RAICHEM(TM) CHLORIDE REAGENT |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
Contact | Peacock, Jr. |
Correspondent | Peacock, Jr. REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-16 |
Decision Date | 1986-09-26 |