Duns Number:051624070
Device Description: Lyphochek Benzo/TCA Control- Set A MiniPak (A human serum assayed benzodiazepines and TCA Lyphochek Benzo/TCA Control- Set A MiniPak (A human serum assayed benzodiazepines and TCA control.)
Catalog Number
660X
Brand Name
Lyphochek
Version/Model Number
660X
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K910829
Product Code
LAS
Product Code Name
DRUG SPECIFIC CONTROL MATERIALS
Public Device Record Key
59df36b2-d6dc-4989-b82c-69d7ea1f0686
Public Version Date
January 23, 2020
Public Version Number
4
DI Record Publish Date
January 09, 2017
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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |