Calcium Liquid Stable Reagent Set
FDA 510(k) K855041 · Medical Analysis Systems, Inc.
510(k) numberK855041
Submission
- Device name
- Calcium Liquid Stable Reagent Set
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- December 17, 1985
- Decision date
- January 22, 1986
- 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 |
|---|---|---|
| K042717 | Mas, Dade and Liquid Assayed Diabetes ControlJJX · Traditional | 11/05/2004SE |
| K041194 | Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HJJX · Traditional | 08/16/2004SE |
| K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3JJY · Traditional | 04/28/2004SE |
| K032826 | Mas Par TDMDIF · Traditional | 10/09/2003SE |
| K032335 | Mas Cardioimmune Probnp, Mas Cardioimmune TLJJY · Traditional | 08/19/2003SE |
| K031890 | Mas Bilirubin Liquid Assayed Bilirubin ControlJJX · Traditional | 07/16/2003SE |
| K031441 | Urichemtrak Liquid Assayed Urine ControlJJW · Traditional | 07/01/2003SE |
| K031392 | Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlDKC · Traditional | 07/01/2003SE |
| K031364 | Mas Cardiolmmune Probnp Liquid Assayed Cardiac Marker Control Level 1, 2 and 3JJY · Traditional | 05/30/2003SE |
| K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlJJY · Traditional | 04/28/2003SE |
Questions and answers
When was Calcium Liquid Stable Reagent Set cleared by the FDA?
Calcium Liquid Stable Reagent Set (K855041) received a 510(k) decision of Substantially Equivalent on January 22, 1986, 36 days after the submission was received.
What is the product code of K855041?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.