Bicarbonate for Manual/Automated Applications
FDA 510(k) K895748 · Catachem, Inc.
510(k) numberK895748
Submission
- Device name
- Bicarbonate for Manual/Automated Applications
- Applicant
- Catachem, Inc.
Port Chester, NY, US - Received
- September 26, 1989
- Decision date
- December 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHS – Enzymatic, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | Teco Diagnostics, Inc. | 06/01/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | Randox Laboratories, Ltd. | 02/24/2016SE |
| K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2)KHS · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/11/2014SE |
| K131546 | Au Bicarbonate ReagentKHS · Traditional | Beckman Coulter Ireland, Inc. | 10/09/2013SE |
| K123953 | Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent…KHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 05/02/2013SE |
| K120765 | Vitros Chemistry Products ECO2 SlidesKHS · Special | Ortho-Clinical Diagnostics, Inc. | 10/24/2012SE |
| K113435 | Ace Carbon DIOXIDE(CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin…KHS · Traditional | Alfa Wassermann | 07/02/2012SE |
| K111960 | Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…KHS · Traditional | Elitechgroup | 11/18/2011SE |
| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 12/15/2010SE |
| K100289 | Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781KHS · Traditional | Siemens Healthcare Diagnostics | 05/10/2010SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | 01/19/2007SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | 02/22/1995SE |
| 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 |
| 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 Bicarbonate for Manual/Automated Applications cleared by the FDA?
Bicarbonate for Manual/Automated Applications (K895748) received a 510(k) decision of Substantially Equivalent on December 21, 1989, 86 days after the submission was received.
What is the product code of K895748?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.