CHLORIDE/TCO2 Analyzer Reagents
FDA 510(k) K803013 · Laboratory Products, Inc.
510(k) numberK803013
Submission
- Device name
- CHLORIDE/TCO2 Analyzer Reagents
- Applicant
- Laboratory Products, Inc.
Mchenry, IL, US - Received
- November 28, 1980
- Decision date
- January 2, 1981
- 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 |
|---|---|---|
| K832588 | Cin AgarJSJ · Traditional | 09/12/1983SE |
| K803051 | Flame Photometry ReagentsJIX · Traditional | 01/09/1981SE |
| K803050 | Spray, Synthetic SmearIFI · Traditional | 12/30/1980SE |
| K800180 | Various Reagents for Blood Cell AnalyzerGIF · Traditional | 03/19/1980SE |
| K792482 | Chemistry Analyzer ReagentsCIX · Traditional | 01/11/1980SE |
| K792481 | Culture Plates & Tubed MediaJTZ · Traditional | 12/31/1979SE |
| K792483 | Stains, Counterstains & Gen. PurposeICL · Traditional | 12/18/1979SE |
Questions and answers
When was CHLORIDE/TCO2 Analyzer Reagents cleared by the FDA?
CHLORIDE/TCO2 Analyzer Reagents (K803013) received a 510(k) decision of Substantially Equivalent on January 2, 1981, 35 days after the submission was received.
What is the product code of K803013?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.