510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940363Substantially Equivalent

Enterovirus 70 Monclonal Antibody

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

K940363 is the FDA 510(k) clearance record for ENTEROVIRUS 70 MONCLONAL ANTIBODY, a class I device, cleared for Light Diagnostics on under FDA product code GOE (Antisera, Fluorescent, Poliovirus 1-3). FDA records list 19 510(k) clearances for Light Diagnostics, from to . As of , FDA records show no recalls naming K940363.

Clearance record

Decision date
Received
(590 days to decision)
Product code
GOE Antisera, Fluorescent, Poliovirus 1-3
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Applicant
Light Diagnostics 28835 Single Oak Dr., Temecula CA
510(k) summary
Summary
Third party review
No

Clearances, product code GOE

Trailing 12 months

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

FDA records show no clearances under product code GOE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GOE, 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