Catalog Number

-

Brand Name

Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays

Version/Model Number

1479

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

K924915

Product Code

JJY

Product Code Name

Multi-analyte controls, all kinds (assayed)

Public Device Record Key

dd2b01b0-68a5-41ad-aeba-2888926590a6

Public Version Date

October 10, 2022

Public Version Number

6

DI Record Publish Date

March 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-