HSV TEST
FDA 510(k) clearance K771063 · decided 1977-07-11
Clearance details
- K-number
- K771063
- Device name
- HSV TEST
- Applicant
- Gull Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-13
- Decision date
- 1977-07-11
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GQL
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.