ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
FDA 510(k) clearance DEN160025 · decided 2017-08-18
Clearance details
- K-number
- DEN160025
- Device name
- ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
- Applicant
- Id-Fish Technology, Inc.
- Decision
- Unknown
- Date received
- 2016-06-27
- Decision date
- 2017-08-18
- Days to decision
- 417 days
- Clearance type
- Direct
- Product code
- PYN
- Device class
- 2
- Regulation number
- 866.3367
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.