510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972975Substantially Equivalent

Light Diagnostics Rabies Dfa Reagent

Light Diagnostics, Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972975 is the FDA 510(k) clearance record for LIGHT DIAGNOSTICS RABIES DFA REAGENT, a class II device, cleared for Light Diagnostics on under FDA product code GOI (Antiserum, Fluorescent, Rabies Virus). FDA records list 19 510(k) clearances for Light Diagnostics, from to . As of , FDA records show no recalls naming K972975.

Clearance record

Decision date
Received
(498 days to decision)
Product code
GOI Antiserum, Fluorescent, Rabies Virus
Regulation
21 CFR 866.3460
Device class
Class II
Review panel
Microbiology
Applicant
Light Diagnostics 28835 Single Oak Dr., Temecula CA
510(k) summary
Summary
Third party review
No

Clearances, product code GOI

Trailing 12 months

FDA records hold no clearances under product code GOI in the trailing twelve months.

FDA records show no clearances under product code GOI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260