510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K990943Substantially Equivalent

Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea Reagent Pack

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

K990943 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code DHX (System, Test, Carcinoembryonic Antigen). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K990943.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DHX System, Test, Carcinoembryonic Antigen
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary
Third party review
No

Clearances, product code DHX

Trailing 12 months

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

FDA records show no clearances under product code DHX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260