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510(k) K021057

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS by Brahms Diagnostica, LLC — Product Code MSW

K021057 is an FDA 510(k) premarket notification submitted by Brahms Diagnostica, LLC for the device "BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS". The FDA issued a decision of Substantially Equivalent on September 17, 2002. The device falls under product code MSW (System, Test, Thyroglobulin), a Class II device regulated under 21 CFR 866.6010. Brahms Diagnostica, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2002
Date Received
April 1, 2002
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

Other clearances by Brahms Diagnostica, LLC

  • K033454 — BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN (March 22, 2004)
  • K000286 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TG (March 17, 2000)
  • K000287 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO (March 17, 2000)
  • K992790 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG (November 12, 1999)
  • K992791 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO (November 12, 1999)

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)
  • K220972 — Access Thyroglobulin (September 15, 2023)
  • K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (May 2, 2003)
  • 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)

FDA data resources