Duns Number:484880690
Device Description: The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-An The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.The system consolidates multiple Analytical instruments into a unified workstation.
Catalog Number
-
Brand Name
FlexLab
Version/Model Number
FLX
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"
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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
K121012
Product Code
CEM
Product Code Name
Electrode, Ion Specific, Potassium
Public Device Record Key
0db7ccee-b2bd-498f-9d67-15e52943bb12
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |