Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Medica Corp. · Predicate Candidate Screening

47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time

326 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K123802	EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT	Medica Corp.	2013-03-01	81	0
K120497	EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MAT	Medica Corp.	2012-05-14	83	0
K111363	PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL	Medica Corp.	2011-12-06	204	0
K111005	ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL	Medica Corp.	2011-11-15	218	0
K112788	EASTLYTE NA/K/CA/PH	Medica Corp.	2011-10-20	24	0
K101089	EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR	Medica Corp.	2011-07-13	450	0
K101090	EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND	Medica Corp.	2011-05-20	396	0
K110675	EASYRA UREA NITROGEN AND CREATININE REAGENTS	Medica Corp.	2011-04-21	42	0
K101088	EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS	Medica Corp.	2011-04-04	350	0
K100829	EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE	Medica Corp.	2011-01-14	296	0
K092116	EASYCELL CELL LOCATOR	Medica Corp.	2010-05-12	302	0
K100187	EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT	Medica Corp.	2010-05-05	103	0
K100673	EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020	Medica Corp.	2010-04-06	28	0
K092737	EASYRA MG REAGENT, MODEL 10220	Medica Corp.	2009-11-17	70	0
K092506	EASYRA GLU-H REAGENT, MODEL 10200	Medica Corp.	2009-09-16	30	0
K091991	EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MOD	Medica Corp.	2009-09-04	64	0
K090734	EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTRO	Medica Corp.	2009-07-17	120	0
K080404	EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTE	Medica Corp.	2009-03-13	393	0
K080874	EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214	Medica Corp.	2009-02-20	326	0
K080810	EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGA	Medica Corp.	2008-12-10	264	0
K080823	EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT	Medica Corp.	2008-11-17	238	0
K073497	HDL CHOLESTEROL REAGENT, MODEL 10211	Medica Corp.	2008-04-14	123	0
K072249	EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT	Medica Corp.	2008-02-20	191	1
K070057	EASYRA CLINICAL CHEMISTRY ANALYZER	Medica Corp.	2007-08-30	237	1
K063376	EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER	Medica Corp.	2007-06-25	229	0
K021515	EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER	Medica Corp.	2002-07-16	67	1
K002407	EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZE	Medica Corp.	2001-02-02	179	0
K000926	EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER	Medica Corp.	2000-05-15	54	0
K990971	EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816	Medica Corp.	1999-04-27	35	0
K974526	EASYBLOOD GAS ANALYZER	Medica Corp.	1998-02-05	65	0
K963763	EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER	Medica Corp.	1996-11-29	71	0
K963992	CAPILLARY ADAPTOR ACCESSORY	Medica Corp.	1996-11-29	56	0
K963694	EASYLYTE CALCIUM/CHLORIDE ANALYZER	Medica Corp.	1996-11-27	72	0
K961326	EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER	Medica Corp.	1996-06-21	74	0
K955374	EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER	Medica Corp.	1996-02-23	91	0
K955375	EASYSTAT SODIUM/POTASSIUM ANALYZER	Medica Corp.	1996-02-23	91	0
K943091	EASY LYTE CALCIUM ANALYZER	Medica Corp.	1995-01-17	203	0
K914810	EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER	Medica Corp.	1991-12-04	40	0
K902237	MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT	Medica Corp.	1990-07-09	52	0
K895936	EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER	Medica Corp.	1989-12-12	62	0
K864872	MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER	Medica Corp.	1987-03-13	91	0
K844044	LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER	Medica Corp.	1984-11-27	41	0
K790759	IIF-APCA TEST KIT	Medica Corp.	1979-07-30	104	0
K790295	TEST KIT, IIF-AMA	Medica Corp.	1979-05-25	105	0
K790430	MEDICA II-F-ASMA TEST KIT	Medica Corp.	1979-04-23	52	0
K790106	IIF-A-N-DNA TEST KIT	Medica Corp.	1979-03-15	56	0
K782048	TEST KIT, IIF-ANA	Medica Corp.	1979-01-17	40	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