510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K061588Substantially Equivalent

Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers

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

K061588 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code LPS (Urinary Homocystine (Nonquantitative) Test System). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show one recall naming K061588.

Clearance record

Decision date
Received
(43 days to decision)
Product code
LPS Urinary Homocystine (Nonquantitative) Test System
Regulation
21 CFR 862.1377
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPS

Trailing 12 months

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

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