510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K042643Substantially Equivalent

Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I and II

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

K042643 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code DCF (Albumin, Antigen, Antiserum, Control). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show one recall naming K042643.

Clearance record

Decision date
Received
(52 days to decision)
Product code
DCF Albumin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
Device class
Class II
Review panel
Immunology
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCF

Trailing 12 months

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

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