Data / Medical devices / United States / Medica Corp.
Medica Corp.: FDA-registered device maker in Bedford, MA, United States, 37 510(k) clearances
Medica Corp. is registered with the FDA (registration 1220972) in Bedford, MA, United States. It lists 56 device types. The FDA files 37 510(k) clearances under its listings, the newest dated December 1, 2016. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1220972
- Address
- 5 Oak Park Drive, Bedford, MA, United States, 01730
- Owner or operator
- MEDICA CORP. (1220972)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 6, 1992
- Registered through
- 2027
- Brand names listed
- ALB,ALP,AST,CO2,CREA,CK EasyRA Reag, AMY,BUN,TRIG,URIC,GLU-H EasyRA Reag, Alanine aminotransferase(ALT) Assay, Amphetamines (AMP), BZO, Barbiturates (BAR), Buprenorphine (BUN), CK-MB EasyRA Reagent and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 1, 2016 | K152327 | EasyLyte Na/K/Cl/Ca Analyzer | JFP | Substantially Equivalent | Medica Corporation | accessdata.fda.gov |
| May 13, 2014 | K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | JHY | Substantially Equivalent | Medica Corporation | accessdata.fda.gov |
| May 15, 2013 | K123586 | EASYRA CREATININE REAGENT | CGX | Substantially Equivalent | Medica Corporation | accessdata.fda.gov |
| March 1, 2013 | K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | CIG | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| June 1, 2012 | K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 14, 2012 | K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL | LCP | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| December 6, 2011 | K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | JXN | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| November 15, 2011 | K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | DIC | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| July 13, 2011 | K101089 | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | DCF | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| June 23, 2011 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | LDJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 30, 2009 | K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 17, 2009 | K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | MRR | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| March 13, 2009 | K080404 | EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR | JIX | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| February 20, 2009 | K080874 | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT | CIX | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| December 10, 2008 | K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT | CIG | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| November 17, 2008 | K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | JFJ | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| April 14, 2008 | K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 | LBS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| February 20, 2008 | K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT | CHH | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| August 30, 2007 | K070057 | EASYRA CLINICAL CHEMISTRY ANALYZER | CGA | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| June 25, 2007 | K063376 | EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER | CHL | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| June 30, 2005 | K050283 | CREATININE LIQUICOLOR | JFY | Substantially Equivalent | Stanbio Laboratory | accessdata.fda.gov |
| June 13, 2005 | K050733 | OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| April 7, 2004 | K033866 | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 3, 2003 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | DIS | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| September 5, 2003 | K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 12, 2002 | K023317 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 16, 2002 | K021515 | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER | CHL | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| February 2, 2001 | K002407 | EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER | JGS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| May 15, 2000 | K000926 | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER | CGZ | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| February 5, 1998 | K974526 | EASYBLOOD GAS ANALYZER | CHL | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| November 29, 1996 | K963992 | CAPILLARY ADAPTOR ACCESSORY | CGZ | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| November 29, 1996 | K963763 | EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER | JGS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| November 27, 1996 | K963694 | EASYLYTE CALCIUM/CHLORIDE ANALYZER | JFP | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| January 17, 1995 | K943091 | EASY LYTE CALCIUM ANALYZER | JFP | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| December 4, 1991 | K914810 | EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER | JGS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| December 12, 1989 | K895936 | EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER | JGS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
| March 13, 1987 | K864872 | MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER | JGS | Substantially Equivalent | Medica Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 31, 2025 | 98315 | Class II | Ongoing | Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. | A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes. | accessdata.fda.gov |
| February 6, 2019 | 82217 | Class II | Terminated | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the we | Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer. | accessdata.fda.gov |
| November 21, 2017 | 79264 | Class II | Terminated | Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1, REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipa | The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist. | accessdata.fda.gov |
| April 11, 2017 | 77160 | Class II | Terminated | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. | Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. | accessdata.fda.gov |
| March 29, 2010 | 55150 | Not yet classified | Terminated | EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits: EasyRA Cuvettes, REF 10700-4 Startup Kit - Chemistry, REF 10990 Startup Kit - Chemistry & ISE, REF 1 | Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette | accessdata.fda.gov |
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Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.