510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K984139Substantially Equivalent

The Aptus (Automated) Application of the Cmv Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the

Zeus Scientific LLC, Branchburg NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984139 is the FDA 510(k) clearance record for THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE, a class II device, cleared for Zeus Scientific, Inc. on under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus). FDA records list 141 510(k) clearances for Zeus Scientific, Inc., from to . As of , FDA records show no recalls naming K984139.

Clearance record

Decision date
Received
(54 days to decision)
Product code
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Zeus Scientific, Inc. 200 Evans Way, Branchburg NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LFZ

Trailing 12 months

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

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