LATEX-R RICKETTSII
FDA 510(k) clearance K843794 · decided 1985-01-04
Clearance details
- K-number
- K843794
- Device name
- LATEX-R RICKETTSII
- Applicant
- Health Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-27
- Decision date
- 1985-01-04
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- GPP
- Device class
- 1
- Regulation number
- 866.3500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Albany, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.