510(k) K101831
- Device
- ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
- Applicant
- BIONOSTICS, INC.
- 510(k) number
- K101831
- Product code
- OSL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-10-01
- Date received
- 2010-07-01
- Regulation
- 864.6550
- Classification name
- Control, Fecal Occult Blood
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MINNA RANNIKKO
- Address
- 7 Jackson Rd. Devens MA US 01434 01434
FDA Registration Numbers#
- 2030538
- 1220649
- 3017772438
- 3014150341
- 3021010433
- 3016837106
- 3005311019
- 1226769
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary