HSV BIO-BEAD SCREEN KIT
FDA 510(k) clearance K791614 · decided 1979-11-13
Clearance details
- K-number
- K791614
- Device name
- HSV BIO-BEAD SCREEN KIT
- Applicant
- Litton Bionetics
- Decision
- Substantially Equivalent
- Date received
- 1979-08-21
- Decision date
- 1979-11-13
- Days to decision
- 84 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.