340-CHLORIDE for Discrete Random Access Analyzer
FDA 510(k) K945408 · Catachem, Inc.
510(k) numberK945408
Submission
- Device name
- 340-CHLORIDE for Discrete Random Access Analyzer
- Applicant
- Catachem, Inc.
Bridgeport, CT, US - Received
- November 3, 1994
- Decision date
- February 22, 1995
- 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
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|---|---|---|---|
| K010670 | Piccolo Chloride Test SystemCHJ · Traditional | Abaxis, Inc. | 04/26/2001SE |
| 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 |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | 01/19/2007SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | 09/08/1993SE |
| K903341 | MagnesiumJGJ · Traditional | 08/22/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | 07/31/1990SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | 07/27/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | 12/21/1989SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | 12/05/1989SE |
| K894715 | Creatine Kinase for Manual/Automated ApplicationsCGS · Traditional | 11/08/1989SE |
| K894476 | Calcium (Arsenazo III) for Manual/Auto ApplicationCJY · Traditional | 10/12/1989SE |
| K894389 | Creatinine for Manual or Automated ApplicationsGGX · Traditional | 10/12/1989SE |
Questions and answers
When was 340-CHLORIDE for Discrete Random Access Analyzer cleared by the FDA?
340-CHLORIDE for Discrete Random Access Analyzer (K945408) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 111 days after the submission was received.
What is the product code of K945408?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.