510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922801Substantially Equivalent

Resp. Panel 1 Indirect Immunofluorescence Assay

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

K922801 is the FDA 510(k) clearance record for RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY, a class I device, cleared for Light Diagnostics on under FDA product code GNY (Antisera, Fluorescent, Adenovirus 1-33). FDA records list 19 510(k) clearances for Light Diagnostics, from to . As of , FDA records show no recalls naming K922801.

Clearance record

Decision date
Received
(210 days to decision)
Product code
GNY Antisera, Fluorescent, Adenovirus 1-33
Regulation
21 CFR 866.3020
Device class
Class I
Review panel
Microbiology
Applicant
Light Diagnostics 27520 Enterprise Cir. W., Temecula CA
510(k) summary
Summary
Third party review
No

Clearances, product code GNY

Trailing 12 months

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

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