Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Instrumentation Laboratory CO — Predicate Candidate Screening

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

62 daysmedian FDA review time
225 days90th percentile
321clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Instrumentation Laboratory CO2023-09-295060
K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO2023-06-232540
K223090GEM Premier ChemSTATInstrumentation Laboratory CO2023-01-271190
K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO2022-12-09300
K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO2022-10-043412
K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO2022-08-162990
K203790GEM Premier 5000Instrumentation Laboratory CO2021-08-2023525
DEN190032HemosIL Liquid Anti-XaInstrumentation Laboratory CO2020-09-174500
K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO2020-08-192250
K183555GEM Premier ChemSTATInstrumentation Laboratory CO2019-02-16580
K183546GEM Premier ChemSTATInstrumentation Laboratory CO2019-02-16580
K183549GEM Premier ChemSTATInstrumentation Laboratory CO2019-02-16580
K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory CO2018-03-22270
K173403GEM Premier 5000Instrumentation Laboratory CO2017-12-29590
K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO2017-11-22610
K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO2017-09-081700
K170314ACL AcuStarInstrumentation Laboratory CO2017-03-03300
K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO2016-12-143061
K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total HemInstrumentation Laboratory CO2016-12-143060
K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, ChlInstrumentation Laboratory CO2016-12-143200
K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and TInstrumentation Laboratory CO2016-12-143060
K160885HemosIL D-Dimer HSInstrumentation Laboratory CO2016-10-272100
K161818GEM Premier 3000Instrumentation Laboratory CO2016-09-14753
K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO2016-07-082520
K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO2016-03-16280
K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL Instrumentation Laboratory CO2016-03-03301
K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; Instrumentation Laboratory CO2015-12-132561
K151534HemosIL D-Dimer HSInstrumentation Laboratory CO2015-07-06280
K133005HEMOSIL VON WILLEBRAND ACTIVITY ASSAYInstrumentation Laboratory CO2014-03-131690
K132722HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)Instrumentation Laboratory CO2014-01-221450
K133407GEM PREMIER 4000Instrumentation Laboratory CO2014-01-13680
K122584HEMOSIL READIPLAS TINInstrumentation Laboratory CO2013-03-242122
K112995GEM PREMIER 4000Instrumentation Laboratory CO2012-05-032090
K113211HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROLInstrumentation Laboratory CO2012-01-04650
K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory CO2011-08-242310
K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory CO2011-07-081630
K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory CO2011-04-052100
K102164HEMOSIL PROTEIN S ACTIVITY ASSAYInstrumentation Laboratory CO2011-03-172270
K093623GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMInstrumentation Laboratory CO2010-06-182075
K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROInstrumentation Laboratory CO2010-05-213590
K093737HEMOSIL F11 & FV DNA CONTROLInstrumentation Laboratory CO2010-05-041510
K092181HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLInstrumentation Laboratory CO2010-03-112330
K090264HEMOSIL D-DIMER HS 500, CONTROLSInstrumentation Laboratory CO2010-02-053670
K090563HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARInstrumentation Laboratory CO2009-10-092210
K091980ACL TOP 700 LASInstrumentation Laboratory CO2009-09-228324
K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HInstrumentation Laboratory CO2009-06-021254
K083518ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMEInstrumentation Laboratory CO2009-03-131070
K082859HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYEDInstrumentation Laboratory CO2008-12-19810
K073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory CO2008-05-041530
K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory CO2007-12-27270

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