Calcium

FDA 510(k) K850929 · Dilab, Inc.

Substantially Equivalent

510(k) numberK850929

Submission

Device name
Calcium
Applicant
Dilab, Inc.
Miami, FL, US
Received
March 7, 1985
Decision date
June 10, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K130870Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)CIC · Traditional Hitachi Chemical Diagnostics, Inc.05/02/2013SE
K083339Dimension RXL Max with Advia Modular Automation System (Amas)CIC · Traditional Siemens Healthcare Diagnostics, Inc.03/09/2009SE
K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HCIC · Traditional Horiba Abx04/26/2007SE
K053401Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional Arkray, Inc.03/24/2006SE
K050077Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen TestsCIC · Traditional Arkray, Inc.02/15/2005SE
K041009Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional Hemagen Diagnostics, Inc.06/25/2004SE
K023105Atac Calcium Reagent and Atac CalibratorCIC · Traditional Elan Diagnostics03/13/2003SE
K013652Wiener Lab. Ca-Color Aa, Model 4 X 50 ML Cat.N 1152002CIC · Traditional Wiener Laboratories Saic12/21/2001SE
K000375Randox CalciumCIC · Traditional Randox Laboratories, Ltd.04/05/2000SE
K991111Buffer 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)DeviceDecision
K862530Rapid AS LatexGTQ · Traditional 04/21/1987SE
K850931AlbuminCIX · Traditional 06/26/1985SE
K850938CholesterolCGO · Traditional 06/25/1985SE
K850936Total ProteinsCEK · Traditional 06/25/1985SE
K850934PhosphorusCEO · Traditional 06/25/1985SE
K850933Uric AcidCDH · Traditional 06/25/1985SE
K850932CreatinineCGX · Traditional 06/25/1985SE
K850937UreaCDW · Traditional 06/10/1985SE
K850935ChlorideCHJ · Traditional 06/10/1985SE
K850930GlucoseCGE · Traditional 06/10/1985SE

Questions and answers

When was Calcium cleared by the FDA?

Calcium (K850929) received a 510(k) decision of Substantially Equivalent on June 10, 1985, 95 days after the submission was received.

What is the product code of K850929?

The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.