510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021057Substantially Equivalent

Brahms Diagnostica Dynotest Tg-Plus

Brahms Diagnostica, LLC, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021057 is the FDA 510(k) clearance record for BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS, a class II device, cleared for Brahms Diagnostica, LLC on under FDA product code MSW (System, Test, Thyroglobulin). FDA records list 6 510(k) clearances for Brahms Diagnostica, LLC, from to . As of , FDA records show no recalls naming K021057.

Clearance record

Decision date
Received
(169 days to decision)
Product code
MSW System, Test, Thyroglobulin
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Brahms Diagnostica, LLC 35 B S. Peachtree St., Norcross GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSW

Trailing 12 months

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

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