510(k) K833814
K833814 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "SANI CATCH BA". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1984
- Date Received
- November 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type