510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063143Substantially Equivalent

Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators

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

K063143 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K063143.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFX

Trailing 12 months

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

FDA records show no clearances under product code LFX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260