510(k) DEN180014
- Device
- WOUNDCHEK Bacterial Status
- Applicant
- Alere Scarborough, Inc.
- 510(k) number
- DEN180014
- Product code
- QFA
- Decision
- Unknown (DENG)
- Decision date
- 2019-12-02
- Date received
- 2018-03-23
- Regulation
- 866.3231
- Classification name
- Assay For Detection Of Proteases In Chronic Wounds
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Angela Drysdale
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 1221359
Source Documents#
510(k) summary PDF not indicated by FDA