Jose Colon

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056435133005643513Jose Colon1N2026-01-01400 College Road East Princeton NJ US 08540

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
20851682658284K992571I-STAT SYSTEMJBP2000-02-10
20851780089293K982071I-STAT LACTATE TESTKHP1998-06-29
20851021752105K973292I-STAT SYSTEMCGL1997-10-20
20851950296043K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
20851754750366K955630RNA MEDICAL HEMAT CONTROLJJR1996-03-01
20851063601215K940918I-STAT 200 PORTABLE CLINICAL ANALYZERCHL1994-05-10
20851181749492K912387I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACKJGS1991-07-01
20852051649266K894914MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACKJGS1989-10-16
20851011231636K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL2025-05-02
20851869291410K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI2025-01-03
20851863875070K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemQAT2024-03-27
20851369434089K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP2023-10-27
20851503017446K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL2023-10-27
20851623246614K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS2023-10-27
20851521986465K223857i-STAT G3+ cartridge with the i-STAT 1 SystemCHL2023-09-15
20851572928967K223755i-STAT G cartridge with the i-STAT 1 SystemCGA2023-09-11
20851101372976K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA2023-07-28
20851849374528K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS2023-07-14
20851778750004K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA2021-08-13
20851954980886K201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemQAT2021-01-08
20852053271327K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemCHL2020-04-09
20851034252893K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFP2020-02-14
20852052576882K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFL2020-02-07
20851874977411K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS2020-02-07
20851753120132K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJPI2020-02-28
20851371882391K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA2020-02-07
20851313203923K153357i-STAT Alinity System with i-STAT Sodium testJGS2016-07-08
20851849222833K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification MaterialsDHA2015-04-16
20851583964840K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEJJX2012-05-18
20851901279803K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2GGN2013-05-31
20851823034111K103195I-STAT 1 WIRELESS ANALYZERCGA2011-02-08
20851330374353K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACJJY2008-06-02
20851548653472K053597I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)NBC2006-07-21
20851518613718K053110Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ CartridgeJGS2006-01-13
20851182756036K051433I-STAT CREATINE KINASE MB (CK-MB)MYT2005-12-15
20851775983640K031739I-STAT CARDIAC TROPONIN (CTNI) TESTMMI2003-09-02
20852062200860K023582I-STAT KAOLIN ACT TESTJBP2003-09-08
20851108487433K020355I-STAT PROTHROMBIN TIME TESTGJS2002-05-14
20851012494152

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JGS62023-10-27
CHL52025-05-02
CGA52023-09-11
MMI22025-01-03
QAT22024-03-27
JFP22023-10-27
GJS22023-07-14
JJY22008-06-02
JBP22003-09-08
JPI12020-02-28
JFL12020-02-07
DHA12015-04-16
GGN12013-05-31
JJX12012-05-18
NBC12006-07-21
MYT12005-12-15
KHP11998-06-29
CGL11997-10-20
JJR11996-03-01