510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994035Substantially Equivalent

Immunodip Urinary Albumin Screen, Model 790-01, 790-15

Sekisui Diagnostics P.E.I. Inc., Charlottetown, P.E., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994035 is the FDA 510(k) clearance record for IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15, a class I device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K994035.

Clearance record

Decision date
Received
(64 days to decision)
Product code
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation
21 CFR 862.1645
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals , Ltd. 16 Mccarville St., Charlottetown, P.E., CA
510(k) summary
Summary
Third party review
No

Clearances, product code JIR

Trailing 12 months

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

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