510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K904456Substantially Equivalent

Cytomegalovirus (Cmv) Elisa

Virotech, Inc., North Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904456 is the FDA 510(k) clearance record for CYTOMEGALOVIRUS (CMV) ELISA, a class II device, cleared for Virotech, Inc. on under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus). FDA records list one 510(k) clearance for Virotech, Inc. As of , FDA records show no recalls naming K904456.

Clearance record

Decision date
Received
(184 days to decision)
Product code
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Virotech, Inc. C/O Schiff & Co., North Caldwell NJ
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFZ, 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