Innovacon, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000057104
- Devices
- 262
- Registrations
- EUDAMED
- FDA recalls
- 1
What Innovacon, Inc. makes
Innovacon, Inc. manufactures in vitro diagnostic devices, including the INNOVACON HCG UKTRA TEST DEVICE, INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE, and INNOVACON SPECTRUM II TEST CARD.
The company's devices are classified as Class II and listed in the FDA 510(k) registry. Innovacon, Inc. is based in the US.
Catalogue
Search and filter all 262 devicesShowing 51-100 of 262
Company details
- EUDAMED SRN
- US-MF-000057104
- EUDAMED status
- Active
- EUDAMED registered name
- Innovacon, Inc.
- EUDAMED abbreviated name
- Innovacon
- Registered address
- 9942, Mesa Rim Road, 92121, San Diego, United States
- [email protected]
- PRRC contact
- Irene Yasuda
FDA recalls
FDA recall records list 1 recall initiated by Innovacon, Inc., initiated on 2007-10-01. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 1 Oct 2007 Z-1118-2008 Unclassified (pre-2012) Terminated Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.