510(k) K972975

LIGHT DIAGNOSTICS RABIES DFA REAGENT by Light Diagnostics — Product Code GOI

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