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TPLC
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show TPLC since
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Device
urinalysis controls (assayed and unassayed)
Product Code
JJW
Regulation Number
862.1660
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
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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