Technicon Chem 1(TM) Syst (GEN2 Syst)
FDA 510(k) K914888 · Technicon Instruments Corp.
510(k) numberK914888
Submission
- Device name
- Technicon Chem 1(TM) Syst (GEN2 Syst)
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- October 30, 1991
- Decision date
- November 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251157 | Core MetabolicCIX · Traditional | Truvian Health | 01/09/2026SE |
| K203248 | Albumin BCG2CIX · Traditional | Abbott Ireland Diagnostics Division | 11/23/2021SE |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…CIX · Traditional | Medicon Hellas S.A | 09/21/2021SE |
| K191316 | VITROS XT Chemistry Products ALB-TP SlidesCIX · Traditional | Ortho-Clinical Diagnostics, Inc. | 06/07/2019SE |
| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional | Biosystems S.A. | 04/13/2018SE |
| K131488 | Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 08/19/2013SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 07/13/2012SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | Polymedco, Inc. | 09/08/2011SE |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | Elitechgroup | 06/21/2011SE |
| K101088 | Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous ReagentCIX · Traditional | Medica Corp. | 04/04/2011SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
| K902243 | Technicon Immuno I(Tm) System and AnalytesKLS · Traditional | 07/05/1990SE |
Questions and answers
When was Technicon Chem 1(TM) Syst (GEN2 Syst) cleared by the FDA?
Technicon Chem 1(TM) Syst (GEN2 Syst) (K914888) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 28 days after the submission was received.
What is the product code of K914888?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.