510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K083680Substantially Equivalent

Vitros Chemistry Products K+dt Slides: Vitros Chemistry Products Dt Calibrator Kit, Model K+dt Slides: 153 2258

Ortho-Clinical Diagnostics, Inc., Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083680 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show one recall naming K083680.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEM

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