Duns Number:658644174
Device Description: PRECICHEK AC300 Blood Glucose Monitoring System.
Catalog Number
3K-01-16003X
Brand Name
PRECICHEK AC300
Version/Model Number
3K-01-16003X
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120064,K120064
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
89519b9b-821a-4fab-9c00-b965442eee30
Public Version Date
July 14, 2020
Public Version Number
1
DI Record Publish Date
July 06, 2020
Package DI Number
04260236851180
Quantity per Package
60
Contains DI Package
04260236851050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |