Catalog Number

K84L2

Brand Name

IMMULITE®2000 Systems 3gAllergy™ Sunflower

Version/Model Number

10385998

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091289

Product Code

DHB

Product Code Name

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Public Device Record Key

465e51ce-eed7-4197-9acc-0c26a73da6d2

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-