510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954687Substantially Equivalent

Access Rubella Igg

Bio-Rad Laboratories Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954687 is the FDA 510(k) clearance record for ACCESS RUBELLA IGG, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K954687.

Clearance record

Decision date
Received
(181 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Bio-Rad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code LFX

Trailing 12 months

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

FDA records show no clearances under product code LFX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260