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510(k) K002905

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER by Beckman Coulter, Inc. — Product Code MSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
September 18, 2000
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

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  • 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)
  • K021057 — BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (September 17, 2002)
  • K002888 — NICHOLS ADVANTAGE THYROGLOB (October 20, 2000)
  • K994140 — NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 (May 9, 2000)
  • K991720 — KRONUS OPTIQUANT THYROGLOBULIN KIT (August 9, 1999)