Catalog Number

-

Brand Name

Actalyke QC Kit - AQC-HP

Version/Model Number

AQC-HP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061014

Product Code

JPA

Product Code Name

SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Public Device Record Key

ba37a67f-d46f-487e-b3f7-60c5fcdf4cdd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-