DENV DETECT IGM CAPTURE ELISA
FDA 510(k) clearance DEN100020 · decided 2011-04-08
Clearance details
- K-number
- DEN100020
- Device name
- DENV DETECT IGM CAPTURE ELISA
- Applicant
- Inbios Intl., Inc.
- Decision
- Unknown
- Date received
- 2010-10-20
- Decision date
- 2011-04-08
- Days to decision
- 170 days
- Clearance type
- Post-NSE
- Product code
- OSU
- Device class
- 2
- Regulation number
- 866.3945
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.