510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083173Substantially Equivalent

Vitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System

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

K083173 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM, a class II device, cleared for Ortho-Clinical Diagnostics on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, from to . As of , FDA records show 26 recalls naming K083173.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics 100 Indigo Creek Dr. Mc881, Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JLW

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