510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922583Substantially Equivalent

Bartels Herpes Simplex Virus 2 Igg Eia

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

K922583 is the FDA 510(k) clearance record for BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K922583.

Clearance record

Decision date
Received
(124 days to decision)
Product code
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Regulation
21 CFR 866.3305
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 LGC

Trailing 12 months

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

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