Device, Hematocrit Measuring

Device Code: 2369

Product Code(s): JPI

Device Classification Information

• Device Type ID: 2369
• Device Name: Device, Hematocrit Measuring
• Regulation Description: Hematocrit Measuring Device.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.6400 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JPI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-104 CLSI H7-A3
  Procedure For Determining Packed Cell Volume By The Microhematocrit Method - Second Edition; Approved Standard - Third Edition.

Total Product Life Cycle

• Device Type ID: 2369
• Device: Device, Hematocrit Measuring
• Product Code: JPI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hematocrit Measuring Device.
• CFR Regulation Number: 864.6400 [🔎]

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Contamination Of Device Ingredient Or Reagent	1
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Contamination During Use	1
Fracture	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 20:10:34