Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests
FDA 510(k) K050077 · Arkray, Inc.
510(k) numberK050077
Submission
- Device name
- Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests
- Applicant
- Arkray, Inc.
Cortlandt Manor, NY, US - Received
- January 12, 2005
- Decision date
- February 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIC – Cresolphthalein Complexone, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130870 | Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)CIC · Traditional | Hitachi Chemical Diagnostics, Inc. | 05/02/2013SE |
| K083339 | Dimension RXL Max with Advia Modular Automation System (Amas)CIC · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/09/2009SE |
| K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HCIC · Traditional | Horiba Abx | 04/26/2007SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | Arkray, Inc. | 03/24/2006SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | Hemagen Diagnostics, Inc. | 06/25/2004SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | Elan Diagnostics | 03/13/2003SE |
| K013652 | Wiener Lab. Ca-Color Aa, Model 4 X 50 ML Cat.N 1152002CIC · Traditional | Wiener Laboratories Saic | 12/21/2001SE |
| K000375 | Randox CalciumCIC · Traditional | Randox Laboratories, Ltd. | 04/05/2000SE |
| K991111 | Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02CIC · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K971907 | Calcium ReagentCIC · Traditional | Carolina Liquid Chemistries Corp. | 06/24/1997SE |
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| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | 12/23/2009SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | 03/24/2006SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | 01/31/2006SE |
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Questions and answers
When was Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests cleared by the FDA?
Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests (K050077) received a 510(k) decision of Substantially Equivalent on February 15, 2005, 34 days after the submission was received.
What is the product code of K050077?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.