510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922580Substantially Equivalent

Bartels Cytomegalovirus Igm Eia

Baxter Diagnostics, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922580 is the FDA 510(k) clearance record for BARTELS CYTOMEGALOVIRUS IGM EIA, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code LKQ (Antibody Igm,If, Cytomegalovirus Virus). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K922580.

Clearance record

Decision date
Received
(316 days to decision)
Product code
LKQ Antibody Igm,If, Cytomegalovirus Virus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Baxter Diagnostics, Inc. Bartels Diagnostics Division, Bellevue WA
510(k) summary
Summary
Third party review
No

Clearances, product code LKQ

Trailing 12 months

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

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