Cobas Reagent for Calcium
FDA 510(k) K823577 · Hoffmann-La Roche, Inc.
510(k) numberK823577
Submission
- Device name
- Cobas Reagent for Calcium
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- January 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from A.P. Total Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
Questions and answers
When was Cobas Reagent for Calcium cleared by the FDA?
Cobas Reagent for Calcium (K823577) received a 510(k) decision of Substantially Equivalent on January 7, 1983, 32 days after the submission was received.
What is the product code of K823577?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.