510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092882Substantially Equivalent

D3 Fastpoint L-Dfa Influenza A/influenza B Virus Identification Kit

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

K092882 is the FDA 510(k) clearance record for D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT, a class I device, cleared for Diagnostic Hybrids, Inc. on under FDA product code GNW (Antisera, Cf, Influenza Virus A, B, C). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K092882.

Clearance record

Decision date
Received
(33 days to decision)
Product code
GNW Antisera, Cf, Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
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 GNW

Trailing 12 months

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

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