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

System, Test, Thyroglobulin

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

MSW is the FDA product code for System, Test, Thyroglobulin, a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
MSW
Device name
System, Test, Thyroglobulin
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
10

Clearances, product code MSW

By decision year
13 clearances under product code MSW with a decision year between 1999 and 2025, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MSW by decision year
YearClearances
19993
20003
20021
20031
20232
20242
20251

Applicants with the most clearances

Product code MSW
Applicants holding the most 510(k) clearances under product code MSW
ApplicantClearances
Siemens Healthcare Diagnostics Inc.8
Nichols Institute Diagnostics2
Brahms Diagnostica, LLC1
Roche Diagnostics GmbH1
Unchanged1

Companies listing this code with FDA

Companies whose registered establishments list this code