510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945913Substantially Equivalent

Irispec Urine Chemistry Control Part a and B

International Remote Imaging Systems, Chartsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945913 is the FDA 510(k) clearance record for IRISPEC URINE CHEMISTRY CONTROL PART A AND B, a class I device, cleared for International Remote Imaging Systems on under FDA product code JJW (Urinalysis Controls (Assayed And Unassayed)). FDA records list 5 510(k) clearances for International Remote Imaging Systems, from to . As of , FDA records show 2 recalls naming K945913.

Clearance record

Decision date
Received
(124 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
International Remote Imaging Systems 9825 De Soto Ave., Chartsworth CA
510(k) summary
Statement
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