The following data is part of a premarket notification filed by A-kem, Inc. with the FDA for Chloride Reagent Kit.
Device ID | K873127 |
510k Number | K873127 |
Device Name: | CHLORIDE REAGENT KIT |
Classification | Coulometric, Chloride |
Applicant | A-KEM, INC. P.O. BOX 1589 82 INDUSTRIAL EAST Clifton, NJ 07015 |
Contact | Steven Lee |
Correspondent | Steven Lee A-KEM, INC. P.O. BOX 1589 82 INDUSTRIAL EAST Clifton, NJ 07015 |
Product Code | JFS |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-10 |
Decision Date | 1987-10-23 |