510(k) K972975
K972975 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "LIGHT DIAGNOSTICS RABIES DFA REAGENT". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code GOI (Antiserum, Fluorescent, Rabies Virus), a Class II device regulated under 21 CFR 866.3460. Light Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1998
- Date Received
- August 11, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Fluorescent, Rabies Virus
- Device Class
- Class II
- Regulation Number
- 866.3460
- Review Panel
- MI
- Submission Type