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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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29 records meeting your search criteria returned- Product Code: CGL Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 01/05/2022
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 08/10/2021
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 06/29/2021
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 05/11/2021
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 02/16/2021
ABBOTT POINT OF CARE CANADA LIMITED ABBOTT ISTAT 06/24/2020
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 06/10/2020
NOVA BIOMEDICAL CORP STAT SENSOR CREAT-TEST STRIPS 05/22/2020
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 04/21/2020
ABBOTT POINT OF CARE I-STAT CREA CARTRIDGE 11/26/2019
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