Catalog Number

1103-120

Brand Name

IMMCO DIAGNOSTICS

Version/Model Number

1103-120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K883883

Product Code

LKJ

Product Code Name

Antinuclear Antibody, Antigen, Control

Public Device Record Key

2b522bf3-26d5-4801-b0ae-d82d849adde9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-