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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinalysis controls (assayed and unassayed)
Product CodeJJW
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLINIQA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTIMETRIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STRECK
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Assuramed II Sep-13-2013
2 Beckman Coulter, Inc. II Jan-03-2023
3 Beckman Coulter, Inc. III Apr-21-2022
4 Cardinal Health Inc. II May-20-2020
5 Iris Diagnostics II May-15-2013
6 Iris Diagnostics III Aug-01-2012
7 Lin-Zhi International Inc II Mar-12-2014
8 Quantimetrix Corporation III Jun-20-2018
9 Quantimetrix Corporation II Jan-17-2009
10 Randox Laboratories Ltd. III Sep-23-2019
11 Siemens Healthcare Diagnostics Inc II Jan-04-2013
12 Siemens Healthcare Diagnostics Inc III Jan-04-2013
13 Thermofisher Scientive III Nov-22-2013
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