510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864811Substantially Equivalent

Rota-Stat

Intl. Diagnostic Laboratories, Ltd., Israel, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864811 is the FDA 510(k) clearance record for ROTA-STAT, a class I device, cleared for Intl. Diagnostic Laboratories, Ltd. on under FDA product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus). FDA records list 4 510(k) clearances for Intl. Diagnostic Laboratories, Ltd., from to . As of , FDA records show no recalls naming K864811.

Clearance record

Decision date
Received
(259 days to decision)
Product code
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Applicant
Intl. Diagnostic Laboratories, Ltd. 91054 Jerusalem, Israel, IL
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