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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nitroprusside, ketones (urinary, non-quant.)
Regulation Description Ketones (nonquantitative) test system.
Product CodeJIN
Regulation Number 862.1435
Device Class 1


Premarket Reviews
ManufacturerDecision
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Feb-28-2020
2 Cardinal Health Inc. II May-20-2020
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
4 Medline Industries Inc II Apr-09-2021
5 Stanbio Laboratory, LP II Dec-06-2023
6 Stanbio Laboratory, LP III Aug-05-2021
7 Universal Meditech Inc. II Oct-23-2023
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