510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001885Substantially Equivalent

Vitros Chemistry Products Bun/urea Slides and Vitros Chemistry Products Calibrator Kit 1

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

K001885 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code CDN (Urease, Photometric, Urea Nitrogen). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show 2 recalls naming K001885.

Clearance record

Decision date
Received
(29 days to decision)
Product code
CDN Urease, Photometric, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary
Third party review
No

Clearances, product code CDN

Trailing 12 months

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

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