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510(k) K972975

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

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

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Other clearances for product code GOI

  • K820499 — FITC ANTI-RABIES MONOCLONAL GLOBULIN (April 16, 1982)