510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K880433Substantially Equivalent

Cytomegalovirus Igg Eia Kit

De Ferris Laboratories, Inc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880433 is the FDA 510(k) clearance record for CYTOMEGALOVIRUS IGG EIA KIT, a class II device, cleared for De Ferris Laboratories, Inc. on under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus). FDA records list 2 510(k) clearances for De Ferris Laboratories, Inc., from to . As of , FDA records show no recalls naming K880433.

Clearance record

Decision date
Received
(420 days to decision)
Product code
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
De Ferris Laboratories, Inc. 26941 Cabot Rd., Suite 119, Laguna Hills CA
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