Olympus Chloride Reagent, Modification
FDA 510(k) K934136 · Olympus Corp.
510(k) numberK934136
Submission
- Device name
- Olympus Chloride Reagent, Modification
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- August 19, 1993
- Decision date
- November 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K072643 | Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/USKZN · Traditional | 11/16/2007SE |
| K043128 | Olympus EndoarmGWG · Traditional | 12/21/2004SE |
| K042140 | Olympus BF Type UC160-OL8ODG · Traditional | 08/18/2004SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | 07/01/2004SE |
| K040940 | Bronchovideoscope Olympus XBF-D160HMEOQ · Traditional | 04/19/2004SE |
| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
| K933200 | Olympus PBD StentsFGE · Traditional | 04/05/1995SE |
| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
Questions and answers
When was Olympus Chloride Reagent, Modification cleared by the FDA?
Olympus Chloride Reagent, Modification (K934136) received a 510(k) decision of Substantially Equivalent on November 5, 1993, 78 days after the submission was received.
What is the product code of K934136?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.