SHIGELLA SERA-CHEK
FDA 510(k) clearance K813191 · decided 1981-12-03
Clearance details
- K-number
- K813191
- Device name
- SHIGELLA SERA-CHEK
- Applicant
- Lab Ability, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-17
- Decision date
- 1981-12-03
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LIA
- Device class
- 2
- Regulation number
- 866.3660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.