510(k) K860947
K860947 is an FDA 510(k) premarket notification submitted by Leeco Diagnostics, Inc. for the device "LEECO-SCREEN, STREP A (EIA)". The FDA issued a decision of Substantially Equivalent on May 13, 1986. 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
- May 13, 1986
- Date Received
- March 12, 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