LATEX R. TYPHI
FDA 510(k) clearance K860557 · decided 1986-04-21
Clearance details
- K-number
- K860557
- Device name
- LATEX R. TYPHI
- Applicant
- Health Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-14
- Decision date
- 1986-04-21
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- GPM
- 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.