510(k) DEN100020
- Device
- DENV DETECT IGM CAPTURE ELISA
- Applicant
- Inbios Intl., Inc.
- 510(k) number
- DEN100020
- Product code
- OSU
- Decision
- Unknown (DENG)
- Decision date
- 2011-04-08
- Date received
- 2010-10-20
- Regulation
- 866.3945
- Classification name
- Dengue Serological Reagents
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- ESTELA I RAYCHAUDHURI
- Address
- 562 1st Ave. S, Suite 600 Seattle WA US 98104 98104
FDA Registration Numbers#
- 2431980
- 3026565854
- 3024756665
- 2023365
- 2029372
- 3032562
Source Documents#
510(k) summary PDF not indicated by FDA