510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043386Substantially Equivalent

Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and Tdm Performance Verifiers I, II and III

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

K043386 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code LEH (Radioimmunoassay, Vancomycin). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show 3 recalls naming K043386.

Clearance record

Decision date
Received
(60 days to decision)
Product code
LEH Radioimmunoassay, Vancomycin
Regulation
21 CFR 862.3950
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LEH

Trailing 12 months

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

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