510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K951359Substantially Equivalent

Rubella Igg Assay for the Technicon Immuno 1 System in-Vitro Diagnostic Device

Bayer Corp., Middletown VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951359 is the FDA 510(k) clearance record for RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE, a class II device, cleared for Bayer Corp. on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list one 510(k) clearance for Bayer Corp. As of , FDA records show no recalls naming K951359.

Clearance record

Decision date
Received
(385 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Bayer Corp. 8365 Valley Pike, Middletown VA
510(k) summary
Summary
Third party review
No

Clearances, product code LFX

Trailing 12 months
1 clearance under product code LFX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260