Chloride Reagent
FDA 510(k) K864713 · Sigma Diagnostics, Inc.
510(k) numberK864713
Submission
- Device name
- Chloride Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- December 3, 1986
- Decision date
- December 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHJ – Mercuric Thiocyanate, Colorimetry, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHJ
| 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 |
More from Intersect Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional | 08/30/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Chloride Reagent cleared by the FDA?
Chloride Reagent (K864713) received a 510(k) decision of Substantially Equivalent on December 31, 1986, 28 days after the submission was received.
What is the product code of K864713?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.