Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)
FDA 510(k) K130870 · Hitachi Chemical Diagnostics, Inc.
510(k) numberK130870
Submission
- Device name
- Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)
- Applicant
- Hitachi Chemical Diagnostics, Inc.
Los Angeles, CA, US - Received
- March 29, 2013
- Decision date
- May 2, 2013
- 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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|---|---|---|---|
| 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 |
| 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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Questions and answers
When was Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca) cleared by the FDA?
Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca) (K130870) received a 510(k) decision of Substantially Equivalent on May 2, 2013, 34 days after the submission was received.
What is the product code of K130870?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.