510(k) K970149
K970149 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "LEGIONELLA ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 18, 1997. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 1997
- Date Received
- January 15, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
- Device Class
- Class II
- Regulation Number
- 866.3300
- Review Panel
- MI
- Submission Type