SeraQuest Herpes Type 1 Specific IgG
FDA 510(k) clearance K162276 · decided 2016-10-01
Clearance details
- K-number
- K162276
- Device name
- SeraQuest Herpes Type 1 Specific IgG
- Applicant
- Quest International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-12
- Decision date
- 2016-10-01
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- MXJ
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.