Il Test Calcium
FDA 510(k) K931362 · Instrumentation Laboratory CO
510(k) numberK931362
Submission
- Device name
- Il Test Calcium
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- March 17, 1993
- Decision date
- February 1, 1994
- 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
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 |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Il Test Calcium cleared by the FDA?
Il Test Calcium (K931362) received a 510(k) decision of Substantially Equivalent on February 1, 1994, 321 days after the submission was received.
What is the product code of K931362?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.