Product code CIC
- Device name
- Cresolphthalein Complexone, Calcium
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1145
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | Hitachi Chemical Diagnostics, Inc. | 2013-05-02 |
| K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | Horiba Abx | 2007-04-26 |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Arkray, Inc. | 2006-03-24 |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | Arkray, Inc. | 2005-02-15 |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | 2004-06-25 |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | 2003-03-13 |
| K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Wiener Laboratories Saic | 2001-12-21 |
| K000375 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 2000-04-05 |
| K991111 | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 | A.P. Total Care, Inc. | 1999-05-25 |
| K971907 | CALCIUM REAGENT | Carolina Liquid Chemistries Corp. | 1997-06-24 |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1996-10-31 |
| K955939 | CALCIUM REAGENT | Derma Media Lab., Inc. | 1996-03-13 |
| K944258 | CALCIUM REAGENT | Olympus America, Inc. | 1995-01-05 |
| K931362 | IL TEST CALCIUM | Instrumentation Laboratory CO | 1994-02-01 |
| K932158 | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | 1993-09-27 |
| K924435 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | 1992-10-19 |
| K923034 | MILES URINE CALCIUM METHOD | Heraeus Kulzer, Inc. | 1992-09-15 |
| K922233 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | 1992-07-10 |
| K921625 | CALCIUM-ARSENAZO III REAGENT SET | Pointe Scientific, Inc., | 1992-05-13 |
| K912027 | CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1992-01-30 |
| K905659 | SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 | Em Diagnostic Systems, Inc. | 1991-01-15 |
| K903233 | SYNERMED CALCIUM REAGENT KIT | Synermed, Inc. | 1990-10-04 |
| K903896 | CALCIUM ARSENAZO III REAGENT | Trace Scientific , Ltd. | 1990-09-13 |
| K896224 | COBAS READY CALCIUM REAGENT | Roche Diagnostic Systems, Inc. | 1990-08-17 |
| K902479 | CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 | Amresco, Inc. | 1990-07-17 |
| K901226 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) | Technicon Instruments Corp. | 1990-04-19 |
| K894407 | ABBOTT SPECTRUM(R) CALCIUM REAGENT | Abbott Laboratories | 1989-09-25 |
| K893778 | CALCIUM TEST ITEM NUMBER: 65409 | Em Diagnostic Systems, Inc. | 1989-09-05 |
| K891217 | IQ CALCIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-03 |
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| 10673486001365 | Teco Diagnostics Calcium Reagent Set | TECO DIAGNOSTICS | 2023-07-25 |
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| 00811727015754 | Pointe Calcium Arsenazo for BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 00852169008119 | ClearChem Diagnostics Inc. Calcium | CLEARCHEM DIAGNOSTICS INC. | 2018-04-30 |
| 00817274022559 | JAS Diagnostics | DREW SCIENTIFIC, INC. | 2017-06-09 |
| 00817439020345 | Calcium / BS480 | Medtest Dx, Inc. | 2016-09-27 |
| 00842768014123 | Dimension® Flex® reagent cartridge CA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 15099590010126 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590020057 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 00842768015618 | Dimension Vista® Flex® reagent cartridge CA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05060500090432 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090456 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090449 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 04015630921355 | Calcium | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921348 | Calcium | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630901999 | Calcium | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273200928 | Ca | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273200911 | Ca | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273200898 | Ca | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 00817274021088 | JAS Diagnostics | DREW SCIENTIFIC, INC. | 2016-09-09 |
| 00817274021095 | JAS Diagnostics | DREW SCIENTIFIC, INC. | 2016-09-09 |
| 00817274021101 | JAS Diagnostics | DREW SCIENTIFIC, INC. | 2016-09-09 |
| 00811727010582 | POINTE SCIENTIFIC Calcium (2 part) | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010599 | POINTE SCIENTIFIC Calcium (2 part) | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010629 | POINTE SCIENTIFIC Calcium Arsenazo | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010636 | POINTE SCIENTIFIC Calcium Arsenazo | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00811727010643 | POINTE SCIENTIFIC Calcium Arsenazo | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |