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510(k) K031269

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2003
Date Received
April 21, 2003
Clearance Type
Special
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)
  • 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)