510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K062165Substantially Equivalent

Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; Fs Calibrator 1; Dat Performance Verifiers

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

K062165 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS, a class II device, cleared for Ortho-Clinical Diagnostics on under FDA product code DIS (Enzyme Immunoassay, Barbiturate). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, from to . As of , FDA records show 5 recalls naming K062165.

Clearance record

Decision date
Received
(161 days to decision)
Product code
DIS Enzyme Immunoassay, Barbiturate
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ortho-Clinical Diagnostics 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DIS

Trailing 12 months

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

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