510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922335Substantially Equivalent

Bartels Rubeola Igm Eia

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

K922335 is the FDA 510(k) clearance record for BARTELS RUBEOLA IGM EIA, a class I device, cleared for Baxter Diagnostics, Inc. on under FDA product code LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg). FDA's definition for product code LJB reads: "The qualitative detection of measles specific IgG antibodies in serum or plasma". FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K922335.

Clearance record

Decision date
Received
(112 days to decision)
Product code
LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Regulation
21 CFR 866.3520
Device class
Class I
Review panel
Microbiology
Applicant
Baxter Diagnostics, Inc. Bartels Diagnostics Division, Bellevue WA
510(k) summary
Summary
Third party review
No

Clearances, product code LJB

Trailing 12 months

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

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