510(k) K813191
K813191 is an FDA 510(k) premarket notification submitted by Lab Ability, Inc. for the device "SHIGELLA SERA-CHEK". The FDA issued a decision of Substantially Equivalent on December 3, 1981. The device falls under product code LIA (Antigens, All Groups, Shigella Spp.), a Class II device regulated under 21 CFR 866.3660. Lab Ability, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1981
- Date Received
- November 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, All Groups, Shigella Spp.
- Device Class
- Class II
- Regulation Number
- 866.3660
- Review Panel
- MI
- Submission Type