510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843189Substantially Equivalent

Cytomegalovirus Igg Eia Test Kit

Labsystems, Inc., IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843189 is the FDA 510(k) clearance record for CYTOMEGALOVIRUS IGG EIA TEST KIT, a class II device, cleared for Labsystems, Inc. on under FDA product code GQI (Antiserum, Cf, Cytomegalovirus). FDA records list 17 510(k) clearances for Labsystems, Inc., from to . As of , FDA records show no recalls naming K843189.

Clearance record

Decision date
Received
(513 days to decision)
Product code
GQI Antiserum, Cf, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Labsystems, Inc.
Third party review
No

Clearances, product code GQI

Trailing 12 months

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

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