510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081164Substantially Equivalent

D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit

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

K081164 is the FDA 510(k) clearance record for D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT, a class II device, cleared for Diagnostic Hybrids, Inc. on under FDA product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K081164.

Clearance record

Decision date
Received
(50 days to decision)
Product code
LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Diagnostic Hybrids, Inc. 1055 E. State St., Suite 100, Athens OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIN

Trailing 12 months

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

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