CHJ · Mercuric Thiocyanate, Colorimetry, Chloride
Clinical Chemistry · 21 CFR 862.1170 · Class 2
Overview
| Product Code | CHJ |
|---|---|
| Device Name | Mercuric Thiocyanate, Colorimetry, Chloride |
| Regulation | 21 CFR 862.1170 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010670 | PICCOLO CHLORIDE TEST SYSTEM | Abaxis, Inc. | Apr 26, 2001 | SESE |
| K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | Catachem, Inc. | Feb 22, 1995 | SESE |
| K943006 | CHLORIDE QVET | Prisma Systems | Dec 7, 1994 | SESE |
| K934136 | OLYMPUS CHLORIDE REAGENT, MODIFICATION | Olympus Corp. | Nov 5, 1993 | SESE |
| K932528 | OLYMPUS CHLORID REAGENT, MODIFIED | Olympus Corp. | Sep 17, 1993 | SESE |
| K925338 | OLYMPUS CHLORIDE REAGENT | Olympus Corp. | Dec 11, 1992 | SESE |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | King Diagnostics, Inc. | Oct 5, 1992 | SESE |
| K923610 | OLYMPUS CHLORIDE REAGENT | Olympus Corp. | Oct 2, 1992 | SESE |
| K923036 | URINE CHLORIDE | Heraeus Kulzer, Inc. | Sep 9, 1992 | SESE |
| K911297 | CHLORIDE REAGENT | Intersect Systems, Inc. | Apr 16, 1991 | SESE |
| K910133 | CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED | Olympus Corp. | Feb 27, 1991 | SESE |
| K901500 | CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. | Olympus Corp. | Jul 10, 1990 | SESE |
| K892929 | TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | Jul 20, 1989 | SESE |
| K890015 | BIOTROL CHLORIDE | Biotrol, USA, Inc. | Feb 17, 1989 | SESE |
| K884601 | TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE | Technicon Instruments Corp. | Jan 27, 1989 | SESE |
| K884706 | CHLORIDE TEST (CL) ITEM #65659 | Em Diagnostic Systems, Inc. | Jan 11, 1989 | SESE |
| K884013 | ROCHE REAGENT FOR CHLORIDE | Roche Diagnostic Systems, Inc. | Dec 9, 1988 | SESE |
| K883386 | CHLORIDE | Tech-Co, Inc. | Oct 6, 1988 | SESE |
| K881240 | CHLORIDE REAGENT SET | Tech-Neal Scientific, Inc. | Apr 28, 1988 | SESE |
| K881200 | CHLORIDE LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | Apr 28, 1988 | SESE |
Top Applicants
- Olympus Corp. — 6 clearances
- Technicon Instruments Corp. — 3 clearances
- Amresco, Inc. — 2 clearances
- Catachem, Inc. — 2 clearances
- Data Medical Associates, Inc. — 2 clearances
