Product code MSW— Immunology

FDA has cleared 13 devices under product code MSW between 1999 and 2025, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20242 clearances
• 20232 clearances
• 20031 clearance
• 20021 clearance
• 20003 clearances
• 19993 clearances

• Beckman Coulter, Inc.5 clearances
• Nichols Institute Diagnostics2 clearances
• Diagnostic Products Corp.2 clearances
• Unchanged1 clearance
• Siemens Healthcare Diagnostics, Inc.1 clearance
• Roche Diagnostics1 clearance
• Brahms Diagnostica, LLC1 clearance

• K242981 — Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.·2025-06-20
• K240927 — Access ThyroglobulinBeckman Coulter, Inc.·2024-06-28
• K241423 — Access ThyroglobulinBeckman Coulter, Inc.·2024-06-07
• K221890 — Elecsys Tg IIRoche Diagnostics·2023-09-30
• K220972 — Access ThyroglobulinBeckman Coulter, Inc.·2023-09-15
• K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.·2003-05-02
• K021057 — BRAHMS DIAGNOSTICA DYNOTEST TG-PLUSBrahms Diagnostica, LLC·2002-09-17
• K002888 — NICHOLS ADVANTAGE THYROGLOBNichols Institute Diagnostics·2000-10-20
• K002905 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZERBeckman Coulter, Inc.·2000-10-19
• K994140 — NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240Nichols Institute Diagnostics·2000-05-09
• K991720 — KRONUS OPTIQUANT THYROGLOBULIN KITUnchanged·1999-08-09
• K982466 — IMMULITE THYROGLOBULIN MODEL LKTYDiagnostic Products Corp.·1999-03-12
• K982468 — IMMULITE 2000 THYROGLOBULIN MODEL L2KTYDiagnostic Products Corp.·1999-03-12