Mercuric Thiocyanate, Colorimetry, Chloride
FDA product code CHJ · Class II (moderate risk) · 21 CFR 862.1170 · Clinical Chemistry
53510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Olympus Corp. 6
- Technicon Instruments Corp. 3
- Diagnostic Chemicals, Ltd. (Usa) 2
- Data Medical Associates, Inc. 2
- Roche Diagnostic Systems, Inc. 2
- Sclavo, Inc. 2
- Catachem, Inc. 2
- Amresco, Inc. 2
- American Monitor Corp. 1
- American Dade 1
- Sigma Chemical Co. 1
- Icn Pharmaceuticals, Inc. 1
- Abaxis, Inc. 1
- Panmed, Inc. 1
- Diagnostic Solutions, Inc. 1
- Gilford Diagnostics 1
- Sandare Chemical Co., Inc. 1
- Volu Sol Medical Industries 1
- Analytical & Research Chemicals, Inc. 1
- Stanbio Laboratory 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010670 | Piccolo Chloride Test SystemCHJ · Traditional | Abaxis, Inc. | 04/26/2001SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | Catachem, Inc. | 02/22/1995SE |
| K943006 | Chloride QvetCHJ · Traditional | Prisma Systems | 12/07/1994SE |
| K934136 | Olympus Chloride Reagent, ModificationCHJ · Traditional | Olympus Corp. | 11/05/1993SE |
| K932528 | Olympus Chlorid Reagent, ModifiedCHJ · Traditional | Olympus Corp. | 09/17/1993SE |
| K925338 | Olympus Chloride ReagentCHJ · Traditional | Olympus Corp. | 12/11/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | King Diagnostics, Inc. | 10/05/1992SE |
| K923610 | Olympus Chloride ReagentCHJ · Traditional | Olympus Corp. | 10/02/1992SE |
| K923036 | Urine ChlorideCHJ · Traditional | Heraeus Kulzer, Inc. | 09/09/1992SE |
| K911297 | Chloride ReagentCHJ · Traditional | Intersect Systems, Inc. | 04/16/1991SE |
| K910133 | Chloride Reagent (C1), Catalog No. DR0011/MODIFIEDCHJ · Traditional | Olympus Corp. | 02/27/1991SE |
| K901500 | Chloride Reagent for the AU5000 Clinical Lab. Ana.CHJ · Traditional | Olympus Corp. | 07/10/1990SE |
| K892929 | Technicon Axon TM System Additional AnalytesCHJ · Traditional | Technicon Instruments Corp. | 07/20/1989SE |
| K890015 | Biotrol ChlorideCHJ · Traditional | Biotrol, USA, Inc. | 02/17/1989SE |
| K884601 | Technicon Systems RA-100/ASSIST ChlorideCHJ · Traditional | Technicon Instruments Corp. | 01/27/1989SE |
| K884706 | Chloride Test (CL) Item #65659CHJ · Traditional | Em Diagnostic Systems, Inc. | 01/11/1989SE |
| K884013 | Roche Reagent for ChlorideCHJ · Traditional | Roche Diagnostic Systems, Inc. | 12/09/1988SE |
| K883386 | ChlorideCHJ · Traditional | Tech-Co, Inc. | 10/06/1988SE |
| K881240 | Chloride Reagent SetCHJ · Traditional | Tech-Neal Scientific, Inc. | 04/28/1988SE |
| K881200 | Chloride Liquid Stable Reagent SetCHJ · Traditional | Medical Analysis Systems, Inc. | 04/28/1988SE |
| K875208 | Chloride Cat. # 152-17CHJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 04/18/1988SE |
| K874812 | Multichem Chloride Reagent S0933CHJ · Traditional | Simmler, Inc. | 12/18/1987SE |
| K870367 | Chloride Reagent - Thiocyanate MethodCHJ · Traditional | Trace Scientific , Ltd. | 08/21/1987SE |
| K872511 | Chloride for Continuous Flow InstrumentsCHJ · Traditional | Catachem, Inc. | 07/21/1987SE |
| K870630 | Chloride TestCHJ · Traditional | Sclavo, Inc. | 04/22/1987SE |
| K864713 | Chloride ReagentCHJ · Traditional | Sigma Diagnostics, Inc. | 12/31/1986SE |
| K863585 | Chloride ProcedureCHJ · Traditional | Data Medical Associates, Inc. | 10/16/1986SE |
| K863620 | Raichem(Tm) Chloride ReagentCHJ · Traditional | Reagents Applications, Inc. | 09/26/1986SE |
| K863061 | ClorofastCHJ · Traditional | J. D. Assoc. | 09/09/1986SE |
| K861674 | Chloride ProcedureCHJ · Traditional | Data Medical Associates, Inc. | 07/01/1986SE |
| K860662 | Amresco Flow Pac Chloride Reagent No. 2256 & 2271CHJ · Traditional | Amresco, Inc. | 03/14/1986SE |
| K852169 | Chloride ReagentCHJ · Traditional | Pointe Scientific, Inc., | 08/21/1985SE |
| K852058 | Chloride Assay KitCHJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/12/1985SE |
| K850935 | ChlorideCHJ · Traditional | Dilab, Inc. | 06/10/1985SE |
| K850334 | Roche Reagent for Chloride, for the CobasCHJ · Traditional | Roche Diagnostic Systems, Inc. | 03/14/1985SE |
| K843740 | Sclavo Chloride TestCHJ · Traditional | Sclavo, Inc. | 10/05/1984SE |
| K842011 | Chloride Test KitCHJ · Traditional | Mallinckrodt Critical Care | 06/22/1984SE |
| K841047 | Paramax Chloride ReagentCHJ · Traditional | American Dade | 04/19/1984SE |
| K834333 | Flow-Pac Chloride Reagent SetCHJ · Traditional | American Research Products Co. | 02/21/1984SE |
| K832438 | Chloride Reagent SetCHJ · Traditional | Amresco, Inc. | 01/20/1984SE |
| K833746 | Tech. RA-1000 Sys Serum ChlorideCHJ · Traditional | Technicon Instruments Corp. | 01/13/1984SE |
| K833166 | Procedure 460 for Determ. of ChlorideCHJ · Traditional | Sigma Chemical Co. | 10/28/1983SE |
| K820235 | TPTZ ChlorideCHJ · Traditional | American Monitor Corp. | 02/12/1982SE |
| K803013 | CHLORIDE/TCO2 Analyzer ReagentsCHJ · Traditional | Laboratory Products, Inc. | 01/02/1981SE |
| K802163 | Chloride Color & Chloride Sample DiluentCHJ · Traditional | Panmed, Inc. | 10/10/1980SE |
| K800683 | Reagent for Determ. Chloride in Human/SmCHJ · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K792605 | Chloride ReagentCHJ · Traditional | Gilford Diagnostics | 01/16/1980SE |
| K792531 | Sandare Chloride ProcedureCHJ · Traditional | Sandare Chemical Co., Inc. | 01/11/1980SE |
| K792400 | Elvi ChlorideCHJ · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K781460 | Chloride ReagentCHJ · Traditional | Analytical & Research Chemicals, Inc. | 10/10/1978SE |
| K781635 | Chloride Test Set, Cat.# 0210CHJ · Traditional | Stanbio Laboratory | 10/03/1978SE |
| K770752 | Reagent, Chloride, CoulterCHJ · Traditional | Coulter Electronics, Inc. | 06/17/1977SE |
| K770450 | Chloride Procedure, Tekpoint DirectCHJ · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |