510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983690Substantially Equivalent

Vitros Immunodiagnostic Products Ca 15-3 Calibrators,vitros Immunodiagnostic Products Ca 15-3 Reagent Pack

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

K983690 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code MOI (System, Test, Immunological, Antigen, Tumor). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K983690.

Clearance record

Decision date
Received
(104 days to decision)
Product code
MOI System, Test, Immunological, Antigen, Tumor
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 MOI

Trailing 12 months

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

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