Duns Number:623238615
Device Description: Total Galactose Cartridge
Catalog Number
307-A950-00
Brand Name
SPOTCHECK
Version/Model Number
307-A950-00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101392
Product Code
JJC
Product Code Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Public Device Record Key
1597208d-b612-4733-835b-5088ad7f380c
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
October 14, 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 | 34 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |