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510(k) K220972

Access Thyroglobulin by Beckman Coulter, Inc. — Product Code MSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
April 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroglobulin
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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Other clearances for product code MSW

  • K242981 — Atellica IM Thyroglobulin (Tg) (June 20, 2025)
  • K240927 — Access Thyroglobulin (June 28, 2024)
  • K241423 — Access Thyroglobulin (June 7, 2024)
  • K221890 — Elecsys Tg II (September 30, 2023)
  • K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (May 2, 2003)
  • K021057 — BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (September 17, 2002)
  • K002888 — NICHOLS ADVANTAGE THYROGLOB (October 20, 2000)
  • K002905 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (October 19, 2000)
  • K994140 — NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 (May 9, 2000)
  • K991720 — KRONUS OPTIQUANT THYROGLOBULIN KIT (August 9, 1999)