Innovacon, Inc.

Medical device manufacturer in San Diego, CA.

3510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K063673Innovacon Flipcard Fecal Occult Blood Test DeviceKHE · Traditional 03/05/2007SE
K061718Innovacon Spectrum II Test CardDKZ · Special 11/13/2006SE
K062361Innovacon HCG Uktra Test DeviceJHI · Traditional 10/23/2006SE

Recalls

RecallProductInitiated
Z-1118-2008 Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog…Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may… 10/01/2007Terminated