H. SIMPLEX VIRUS
FDA 510(k) clearance K843658 · decided 1985-09-26
Clearance details
- K-number
- K843658
- Device name
- H. SIMPLEX VIRUS
- Applicant
- Institute Virion , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-17
- Decision date
- 1985-09-26
- Days to decision
- 374 days
- Clearance type
- Traditional
- Product code
- GQN
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.