Atac Calcium Reagent and Atac Calibrator
FDA 510(k) K023105 · Elan Diagnostics
510(k) numberK023105
Submission
- Device name
- Atac Calcium Reagent and Atac Calibrator
- Applicant
- Elan Diagnostics
Brea, CA, US - Received
- September 18, 2002
- Decision date
- March 13, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
| K050077 | Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen TestsCIC · Traditional | Arkray, Inc. | 02/15/2005SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | Hemagen Diagnostics, Inc. | 06/25/2004SE |
| 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 |
More from Carolina Liquid Chemistries Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | 03/19/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | 03/07/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | 04/12/2002SE |
| K002285 | Atac Pak Alp Reagent KitCJE · Traditional | 09/26/2000SE |
Questions and answers
When was Atac Calcium Reagent and Atac Calibrator cleared by the FDA?
Atac Calcium Reagent and Atac Calibrator (K023105) received a 510(k) decision of Substantially Equivalent on March 13, 2003, 176 days after the submission was received.
What is the product code of K023105?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.