510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093861Substantially Equivalent

Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle

Iris International, Inc., Chatsworth CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093861 is the FDA 510(k) clearance record for IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE, a class II device, cleared for Iris International, Inc. on under FDA product code LKM (Counter, Urine Particle). FDA records list 3 510(k) clearances for Iris International, Inc., from to . As of , FDA records show 4 recalls naming K093861.

Clearance record

Decision date
Received
(51 days to decision)
Product code
LKM Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Iris International, Inc. 9172 Eton Ave., Chatsworth CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKM

Trailing 12 months

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

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