510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K912666Substantially Equivalent

Dako Elisa Rotavirus Kit- 96 Tests K440

Dako Corp., Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912666 is the FDA 510(k) clearance record for DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440, a class I device, cleared for Dako Corp. on under FDA product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus). FDA records list one 510(k) clearance for Dako Corp. As of , FDA records show no recalls naming K912666.

Clearance record

Decision date
Received
(241 days to decision)
Product code
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Applicant
Dako Corp. P.O. Box 1359, Denmark, DK
510(k) summary
Statement
Third party review
No

Clearances, product code LIQ

Trailing 12 months

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

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