Coulometric, Chloride
Clinical Chemistry · 21 CFR 862.1170
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Siemens Healthcare Diagnostics IncTerminatedSep 30, 2016
Siemens RAPIDPoint 400 Measurement Cartridge
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Z-2912-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedSep 30, 2016
Siemens RAPIDPoint 405 Measurement Cartridge
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Z-2913-2016 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
19 clearances for this product code
- Wescor, Inc.Mar 27, 2013
K121823 · CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
- Awareness Technology, Inc.Oct 14, 1992
K923598 · REDI-CHECK PHOTMETER Q.A.
- A-Kem, Inc.Oct 23, 1987
K873127 · CHLORIDE REAGENT KIT
- Fisher Scientific Co., LLCFeb 18, 1983
K830217 · REAGENTS CORNING CHLORIDE METER FOR
- Fermco Biochemics, Inc.Nov 16, 1982
K823106 · RERMCO TEST CHLORIDE REAGENT
- American Research Products Co.Mar 8, 1982
K820411 · LIQUIZYME CHLORIDE REAGENT
- Chem-Elec, Inc.Aug 13, 1981
K811319 · CHLORIDE REAGENT KIT
- Chem-Elec, Inc.Jul 1, 1981
K811701 · CHLORIDE/CARBON DIOXIDE RATE REAGENT