RICKETTSIAL IGG AND IGM IFA KIT
FDA 510(k) clearance K864110 · decided 1987-03-12
Clearance details
- K-number
- K864110
- Device name
- RICKETTSIAL IGG AND IGM IFA KIT
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1986-10-21
- Decision date
- 1987-03-12
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GPN
- Device class
- 1
- Regulation number
- 866.3500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.