FDA.reportPublic FDA data

ABBOTT POINT OF CARE INC.

Matched from indexed company URL: ABBOTT POINT OF CARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22455782245578ABBOTT POINT OF CARE INC.1Y2026-01-01400 College Road East Princeton NJ US 08540

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00054749001385i-STAT - IST DISPENSING TIP+1(800)366-8020techsvc@apoc.abbott.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
20921950296043K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
20921011231636K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL2025-05-02
20921869291410K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI2025-01-03
20921863875070K234143i-STAT TBI Cartridge with the i-STAT Alinity SystemQAT2024-03-27
20921369434089K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP2023-10-27
20921503017446K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL2023-10-27
20921623246614K230275i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS2023-10-27
20921521986465K223857i-STAT G3+ cartridge with the i-STAT 1 SystemCHL2023-09-15
20921572928967K223755i-STAT G cartridge with the i-STAT 1 SystemCGA2023-09-11
20921101372976K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA2023-07-28
20921849374528K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS2023-07-14
20921778750004K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA2021-08-13
20921954980886K201778i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemQAT2021-01-08
20922053271327K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemCHL2020-04-09
20921034252893K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFP2020-02-14
20922052576882K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFL2020-02-07
20921874977411K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS2020-02-07
20921753120132K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJPI2020-02-28
20921371882391K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA2020-02-07
20921313203923K153357i-STAT Alinity System with i-STAT Sodium testJGS2016-07-08
20921583964840K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEJJX2012-05-18
20921901279803K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2GGN2013-05-31
20921823034111K103195I-STAT 1 WIRELESS ANALYZERCGA2011-02-08
20921330374353K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACJJY2008-06-02
20921308395235K001387I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300CGA2000-10-05
20921344342077
20921012494152
20921319673240

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CGA62023-09-11
CHL42025-05-02
JGS32023-10-27
QAT22024-03-27
JFP22023-10-27
JJY22008-06-02
MMI12025-01-03
GJS12023-07-14
JPI12020-02-28
JFL12020-02-07
GGN12013-05-31
JJX12012-05-18

PMN#

GUDID#

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