510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973448Substantially Equivalent

Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469

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

K973448 is the FDA 510(k) clearance record for ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469, a class II device, cleared for Beckman Instruments, Inc. on under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K973448.

Clearance record

Decision date
Received
(371 days to decision)
Product code
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Beckman Instruments, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code LGD

Trailing 12 months

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

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