510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831623Substantially Equivalent

Dia Strips System

California Immuno Diagnostic, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831623 is the FDA 510(k) clearance record for DIA STRIPS SYSTEM, a class I device, cleared for California Immuno Diagnostic, Inc. on under FDA product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)). FDA records list 3 510(k) clearances for California Immuno Diagnostic, Inc., from to . As of , FDA records show no recalls naming K831623.

Clearance record

Decision date
Received
(69 days to decision)
Product code
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Regulation
21 CFR 862.1785
Device class
Class I
Review panel
Clinical Chemistry
Applicant
California Immuno Diagnostic, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CDM

Trailing 12 months

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

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