Chloride Reagent (C1), Catalog No. DR0011/MODIFIED
FDA 510(k) K910133 · Olympus Corp.
510(k) numberK910133
Submission
- Device name
- Chloride Reagent (C1), Catalog No. DR0011/MODIFIED
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- January 9, 1991
- Decision date
- February 27, 1991
- 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 |
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| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
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Questions and answers
When was Chloride Reagent (C1), Catalog No. DR0011/MODIFIED cleared by the FDA?
Chloride Reagent (C1), Catalog No. DR0011/MODIFIED (K910133) received a 510(k) decision of Substantially Equivalent on February 27, 1991, 49 days after the submission was received.
What is the product code of K910133?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.