510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832713Substantially Equivalent

Iri Spec Urinalysis Control

Intl. Remote Imaging Systems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832713 is the FDA 510(k) clearance record for IRI SPEC URINALYSIS CONTROL, a class I device, cleared for Intl. Remote Imaging Systems on under FDA product code JJW (Urinalysis Controls (Assayed And Unassayed)). FDA records list 14 510(k) clearances for Intl. Remote Imaging Systems, from to . As of , FDA records show one recall naming K832713.

Clearance record

Decision date
Received
(132 days to decision)
Product code
JJW Urinalysis Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Intl. Remote Imaging Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJW

Trailing 12 months

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

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