The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Chloride Reagent.
Device ID | K911297 |
510k Number | K911297 |
Device Name: | CHLORIDE REAGENT |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E P.O. BOX 2219 Longview, WA 98632 |
Contact | Mark E Legaz |
Correspondent | Mark E Legaz INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E P.O. BOX 2219 Longview, WA 98632 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-25 |
Decision Date | 1991-04-16 |