510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medica Corp.

Bedford, MA, US

MEDICA CORP. appears in FDA device records in Bedford, MA. FDA records list 56 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
56
PMA records
0
Recall records
5
Registered establishments
2

510(k) clearance history

Showing 50 of 56

FDA records hold 56 510(k) clearances for Medica Corp. between 1979 and 2024. The busiest year on record is 2011, with 9. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medica Corp., by decision year
YearClearances
19795
19841
19871
19891
19901
19911
19951
19966
19981
19992
20001
20012
20021
20072
20084
20096
20103
20119
20121
20132
20141
20161
20232
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220328EasyStat 300CGASubstantially Equivalent
K220396EasyStat 300CEMSubstantially Equivalent
K211559EasyStat 300CHLSubstantially Equivalent
K152327EasyLyte Na/K/Cl/Ca AnalyzerJFPSubstantially Equivalent
K130080EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIALJHYSubstantially Equivalent
K123586EASYRA CREATININE REAGENTCGXSubstantially Equivalent
K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTCIGSubstantially Equivalent
K120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALLCPSubstantially Equivalent
K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALJXNSubstantially Equivalent
K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALDICSubstantially Equivalent
K112788EASTLYTE NA/K/CA/PHCEMSubstantially Equivalent
K101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORDCFSubstantially Equivalent
K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTLBSSubstantially Equivalent
K101090EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTSCJESubstantially Equivalent
K110675EASYRA UREA NITROGEN AND CREATININE REAGENTSCDQSubstantially Equivalent
K101088EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTCIXSubstantially Equivalent
K100829EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520JGSSubstantially Equivalent
K092116EASYCELL CELL LOCATORJOYSubstantially Equivalent
K100187EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENTCGASubstantially Equivalent
K100673EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020JGSSubstantially Equivalent
K092737EASYRA MG REAGENT, MODEL 10220JGJSubstantially Equivalent
K092506EASYRA GLU-H REAGENT, MODEL 10200CFRSubstantially Equivalent
K091991EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200CIGSubstantially Equivalent
K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMRRSubstantially Equivalent
K080404EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATORJIXSubstantially Equivalent
K080874EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENTCIXSubstantially Equivalent
K080810EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENTCIGSubstantially Equivalent
K080823EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENTJFJSubstantially Equivalent
K073497HDL CHOLESTEROL REAGENT, MODEL 10211LBSSubstantially Equivalent
K072249EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENTCHHSubstantially Equivalent
K070057EASYRA CLINICAL CHEMISTRY ANALYZERCGASubstantially Equivalent
K063376EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZERCHLSubstantially Equivalent
K021515EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZERCHLSubstantially Equivalent
K000724MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300KDISubstantially Equivalent
K002407EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZERJGSSubstantially Equivalent
K000926EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERCGZSubstantially Equivalent
K993034MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESDMVMSubstantially Equivalent
K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816JJRSubstantially Equivalent
K974526EASYBLOOD GAS ANALYZERCHLSubstantially Equivalent
K963992CAPILLARY ADAPTOR ACCESSORYCGZSubstantially Equivalent
K963763EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZERJGSSubstantially Equivalent
K963694EASYLYTE CALCIUM/CHLORIDE ANALYZERJFPSubstantially Equivalent
K961326EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZERCEMSubstantially Equivalent
K955375EASYSTAT SODIUM/POTASSIUM ANALYZERJGSSubstantially Equivalent
K955374EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZERJGSSubstantially Equivalent
K943091EASY LYTE CALCIUM ANALYZERJFPSubstantially Equivalent
K914810EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZERJGSSubstantially Equivalent
K902237MEDICA IIF ANTI-SKIN ANTIBODY TEST KITDBLSubstantially Equivalent
K895936EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZERJGSSubstantially Equivalent
K864872MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZERJGSSubstantially Equivalent

Registered establishments

FDA registered establishments for Medica Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12209721220972MEDICA CORP.5 OAK PARK DRIVE, BEDFORD, MA 01730 US2026and 46 more, listed in full below
96159421000191953Medica S.p.A.via degli Artigiani, 7, Medolla Modena 41036 IT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1370-2026Medica 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.Class IIOpen, Classified
Z-1294-2019Medica 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 wedge is used to prevent interference between certain tests.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.Class IITerminated
Z-1149-2018Wash 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 lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.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.Class IITerminated
Z-1267-2018EasyCAL 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.Class IITerminated
Z-0078-2011EasyRA 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 10991Chemistry 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 dimensions with a Co-ordinate MeasuriTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain