Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device counter, urine particle
Product CodeLKM
Regulation Number 864.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Device Emits Odor 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Obstruction of Flow 1 1
High Test Results 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jan-29-2020
2 Beckman Coulter, Inc. II Jan-25-2024
-
-