Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIC — Predicate Candidate Screening
99 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
117 days90th percentile
99clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM ( | Hitachi Chemical Diagnostics, Inc. | 2013-05-02 | 34 | 0 |
| K083339 | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS | Siemens Healthcare Diagnostics, Inc. | 2009-03-09 | 117 | 0 |
| K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AM | Horiba Abx | 2007-04-26 | 90 | 1 |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Arkray, Inc. | 2006-03-24 | 108 | 1 |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TEST | Arkray, Inc. | 2005-02-15 | 34 | 0 |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | 2004-06-25 | 67 | 1 |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | 2003-03-13 | 176 | 0 |
| K013652 | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Wiener Laboratories Saic | 2001-12-21 | 45 | 0 |
| K000375 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 2000-04-05 | 58 | 0 |
| K991111 | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2 | A.P. Total Care, Inc. | 1999-05-25 | 54 | 0 |
| K971907 | CALCIUM REAGENT | Carolina Liquid Chemistries Corp. | 1997-06-24 | 32 | 0 |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1996-10-31 | 71 | 2 |
| K955939 | CALCIUM REAGENT | Derma Media Lab., Inc. | 1996-03-13 | 83 | 0 |
| K944258 | CALCIUM REAGENT | Olympus America, Inc. | 1995-01-05 | 126 | 0 |
| K931362 | IL TEST CALCIUM | Instrumentation Laboratory CO | 1994-02-01 | 321 | 0 |
| K932158 | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | 1993-09-27 | 146 | 0 |
| K924435 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | 1992-10-19 | 48 | 0 |
| K923034 | MILES URINE CALCIUM METHOD | Heraeus Kulzer, Inc. | 1992-09-15 | 88 | 0 |
| K922233 | OLYMPUS CALCIUM REAGENT | Olympus Corp. | 1992-07-10 | 59 | 0 |
| K921625 | CALCIUM-ARSENAZO III REAGENT SET | Pointe Scientific, Inc., | 1992-05-13 | 37 | 0 |
| K912027 | CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1992-01-30 | 267 | 0 |
| K905659 | SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 | Em Diagnostic Systems, Inc. | 1991-01-15 | 29 | 0 |
| K903233 | SYNERMED CALCIUM REAGENT KIT | Synermed, Inc. | 1990-10-04 | 73 | 0 |
| K903896 | CALCIUM ARSENAZO III REAGENT | Trace Scientific , Ltd. | 1990-09-13 | 21 | 0 |
| K896224 | COBAS READY CALCIUM REAGENT | Roche Diagnostic Systems, Inc. | 1990-08-17 | 291 | 0 |
| K902479 | CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 | Amresco, Inc. | 1990-07-17 | 42 | 0 |
| K901226 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) | Technicon Instruments Corp. | 1990-04-19 | 36 | 0 |
| K894407 | ABBOTT SPECTRUM(R) CALCIUM REAGENT | Abbott Laboratories | 1989-09-25 | 70 | 0 |
| K893778 | CALCIUM TEST ITEM NUMBER: 65409 | Em Diagnostic Systems, Inc. | 1989-09-05 | 106 | 0 |
| K891217 | IQ CALCIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-03 | 57 | 0 |
| K884599 | TECHNICON RA-100 SYSTEM CALCIUM METHOD | Technicon Instruments Corp. | 1989-01-27 | 85 | 0 |
| K884986 | CALCIUM TEST ITEM NUMBER: SR1009 | Em Diagnostic Systems, Inc. | 1989-01-13 | 43 | 0 |
| K884480 | BIOTROL BILIRUBIN MONOREACTIF | Biotrol, USA, Inc. | 1988-11-29 | 35 | 0 |
| K884433 | TECHNICON ASSIST(R) CALCIUM METHOD | Technicon Instruments Corp. | 1988-11-29 | 39 | 0 |
| K882586 | A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM | A-Kem, Inc. | 1988-08-08 | 46 | 0 |
| K880308 | CALCIUM | Catachem, Inc. | 1988-05-27 | 123 | 0 |
| K881054 | CALCIUM, CATALOGUE NUMBER 122-20 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | 38 | 0 |
| K880845 | CALCIUM REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | 39 | 0 |
| K874496 | CALCIUM ASSAY KIT, NUMBER 120-19 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-11 | 101 | 0 |
| K873519 | PARAMAX CALCIUM REAGENT | Baxter Healthcare Corp | 1987-12-14 | 104 | 0 |
| K874131 | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Pointe Scientific, Inc., | 1987-12-04 | 52 | 0 |
| K873334 | WAKO(TM) AUTOKIT CALCIUM | Wako Chemicals USA, Inc. | 1987-10-02 | 44 | 0 |
| K873697 | MULTICHEM CALCIUM S0910 | Simmler, Inc. | 1987-10-02 | 18 | 0 |
| K870362 | CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD | Trace Scientific , Ltd. | 1987-08-21 | 205 | 0 |
| K872306 | SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) | Boehringer Mannheim Corp. | 1987-08-18 | 64 | 0 |
| K871152 | SIGMA'S CALCIUM PROCEDURE NO. 587 | Sigma Diagnostics, Inc. | 1987-06-12 | 81 | 1 |
| K871811 | SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) | Boehringer Mannheim Corp. | 1987-05-26 | 18 | 0 |
| K870629 | CALCIUM TEST | Sclavo, Inc. | 1987-04-29 | 75 | 0 |
| K870170 | EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 | Em Diagnostic Systems, Inc. | 1987-03-06 | 51 | 0 |
| K864661 | UNIFAST CALCIUM TEST | Sclavo, Inc. | 1987-02-04 | 68 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda