510(k) K864170
K864170 is an FDA 510(k) premarket notification submitted by Leeco Diagnostics, Inc. for the device "LEECO VIS-CUBE STREP A (EIA)". The FDA issued a decision of Substantially Equivalent on February 3, 1987. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Leeco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1987
- Date Received
- October 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, All Groups, Streptococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type