510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052819Substantially Equivalent

Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and III

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

K052819 is the FDA 510(k) clearance record for VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K052819.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DEM

Trailing 12 months

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

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