Catalog Number

HC-105P

Brand Name

Hemoglobin AC Control Powder

Version/Model Number

HC-105P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K802569

Product Code

KHG

Product Code Name

Whole Blood Hemoglobin Determination

Public Device Record Key

069cdc47-7465-4742-8644-564709c52c71

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-