CIC · Cresolphthalein Complexone, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | CIC |
|---|---|
| Device Name | Cresolphthalein Complexone, Calcium |
| Regulation | 21 CFR 862.1145 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Classification Rationale
Class II.
Recent Cleared Devices (20 of 99)
Showing 20 most recent of 99 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | Hitachi Chemical Diagnostics, Inc. | May 2, 2013 | SESE |
| K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | Siemens Healthcare Diagnostics, Inc. | Mar 9, 2009 | SESE |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | Horiba Abx | Apr 26, 2007 | SESE |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Arkray, Inc. | Mar 24, 2006 | SESE |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | Arkray, Inc. | Feb 15, 2005 | SESE |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | Jun 25, 2004 | SESE |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | Mar 13, 2003 | SESE |
| K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Wiener Laboratories Saic | Dec 21, 2001 | SESE |
| K000375 | RANDOX CALCIUM | Randox Laboratories, Ltd. | Apr 5, 2000 | SESE |
| K991111 | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 | A.P. Total Care, Inc. | May 25, 1999 | SESE |
| K971907 | CALCIUM REAGENT | Carolina Liquid Chemistries Corp. | Jun 24, 1997 | SESE |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | Oct 31, 1996 | SESE |
| K955939 | CALCIUM REAGENT | Derma Media Lab., Inc. | Mar 13, 1996 | SESE |
| K944258 | CALCIUM REAGENT | Olympus America, Inc. | Jan 5, 1995 | SESE |
| K931362 | IL TEST CALCIUM | Instrumentation Laboratory CO | Feb 1, 1994 | SESE |
| K932158 | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | Sep 27, 1993 | SESE |
| K924435 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | Oct 19, 1992 | SESE |
| K923034 | MILES URINE CALCIUM METHOD | Heraeus Kulzer, Inc. | Sep 15, 1992 | SESE |
| K922233 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | Jul 10, 1992 | SESE |
| K921625 | CALCIUM-ARSENAZO III REAGENT SET | Pointe Scientific, Inc., | May 13, 1992 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 7 clearances
- Abbott Laboratories — 3 clearances
- American Research Products Co. — 3 clearances
- Boehringer Mannheim Corp. — 3 clearances
- Diagnostic Chemicals, Ltd. (Usa) — 3 clearances
