510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K944438Substantially Equivalent

Hemagen Cmv Igg Kit

Hemagen Diagnostics, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944438 is the FDA 510(k) clearance record for HEMAGEN CMV IGG KIT, a class II device, cleared for Hemagen Diagnostics, Inc. on under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K944438.

Clearance record

Decision date
Received
(892 days to decision)
Product code
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Hemagen Diagnostics, Inc. 34 Bear Hill Rd., Waltham MA
510(k) summary
Summary
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