Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02
FDA 510(k) K991111 · A.P. Total Care, Inc.
510(k) numberK991111
Submission
- Device name
- Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02
- Applicant
- A.P. Total Care, Inc.
Bridgeport, CT, US - Received
- April 1, 1999
- Decision date
- May 25, 1999
- 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 |
| 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 |
| K971907 | Calcium ReagentCIC · Traditional | Carolina Liquid Chemistries Corp. | 06/24/1997SE |
More from Carolina Liquid Chemistries Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | 12/16/1999SE |
| K991762 | Alkaline Phophatase (Alp), Product No's 118-01, 118-02CJE · Traditional | 09/02/1999SE |
| K991761 | Magnesium Product No's, 112-01, 112-02JGJ · Traditional | 09/02/1999SE |
| K991664 | LDL Cholesterol, Product No's, 124-01, CH102-01LBS · Traditional | 08/19/1999SE |
| K991665 | HDL Cholesterol, Product No's 124-01, CH102-01LBS · Traditional | 08/10/1999SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | 08/02/1999SE |
| K991866 | Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04CIG · Traditional | 08/02/1999SE |
| K991870 | Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03CGZ · Traditional | 07/30/1999SE |
| K991666 | Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02JMO · Traditional | 06/30/1999SE |
| K991663 | Ast/SgotCIT · Traditional | 06/30/1999SE |
Questions and answers
When was Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02 cleared by the FDA?
Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02 (K991111) received a 510(k) decision of Substantially Equivalent on May 25, 1999, 54 days after the submission was received.
What is the product code of K991111?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.