510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K984289Substantially Equivalent

Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa Reagent Pack

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

K984289 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K984289.

Clearance record

Decision date
Received
(101 days to decision)
Product code
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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 LTJ

Trailing 12 months
1 clearance under product code LTJ in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LTJ, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260