Akers Biosciences, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
4
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K102338BREATHSCN PROJanuary 12, 2011
K062971BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMSDecember 18, 2006
K060761BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORSApril 28, 2006
K052697HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANELJanuary 4, 2006
K050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEMMarch 4, 2005