510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081527Substantially Equivalent

Light Diagnostics Hsv 1/2 Typing Dfa Kit

EMD Millipore Corporation, Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081527 is the FDA 510(k) clearance record for LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT, a class II device, cleared for Millipore Corporation on under FDA product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K081527.

Clearance record

Decision date
Received
(303 days to decision)
Product code
GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Millipore Corporation 28820 Single Oak Dr., Temecula CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GQL

Trailing 12 months

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

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