LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
FDA 510(k) clearance K852237 · decided 1985-08-22
Clearance details
- K-number
- K852237
- Device name
- LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
- Applicant
- Genetic Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-22
- Decision date
- 1985-08-22
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- LHL
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.