510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083391Substantially Equivalent

Thyroid Stimulating Immunoglobulin Reporter Assay

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

K083391 is the FDA 510(k) clearance record for THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY, a class II device, cleared for Diagnostic Hybrids, Inc. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K083391.

Clearance record

Decision date
Received
(185 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Diagnostic Hybrids, Inc. 1055 E. State St., Suite 100, Athens OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JZO

Trailing 12 months

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

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