510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981354Substantially Equivalent

Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211

Beckman Instruments, Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981354 is the FDA 510(k) clearance record for ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211, a class II device, cleared for Beckman Instruments, Inc. on under FDA product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show one recall naming K981354.

Clearance record

Decision date
Received
(17 days to decision)
Product code
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Beckman Instruments, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code LOJ

Trailing 12 months

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

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