510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K001769Substantially Equivalent

Vitros Chemistry Products Crea Dt Slides; Vitros Chemistry Products Dt Calibrator Kit

Ortho-Clinical Diagnostics, Inc., Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001769 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, a class II device, cleared for Ortho-Clinical Diagnostics on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, from to . As of , FDA records show no recalls naming K001769.

Clearance record

Decision date
Received
(9 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary
Third party review
No

Clearances, product code CGX

Trailing 12 months
1 clearance under product code CGX in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGX, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260