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 device, hematocrit measuring
Regulation Description Hematocrit measuring device.
Product CodeJPI
Regulation Number 864.6400
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 17 17
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
Dizziness 2 2
Head Injury 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Heart Failure/Congestive Heart Failure 2 2
Renal Failure 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Abdominal Pain 1 1
High Blood Pressure/ Hypertension 1 1
Stroke/CVA 1 1
Sepsis 1 1
Genital Bleeding 1 1
Diabetic Ketoacidosis 1 1
Atrial Fibrillation 1 1
Cardiac Arrest 1 1
Pneumonia 1 1
Swelling/ Edema 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Ischemia Stroke 1 1

-
-