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510(k) K991720

KRONUS OPTIQUANT THYROGLOBULIN KIT by Unchanged — Product Code MSW

K991720 is an FDA 510(k) premarket notification submitted by Unchanged for the device "KRONUS OPTIQUANT THYROGLOBULIN KIT". The FDA issued a decision of Substantially Equivalent on August 9, 1999. The device falls under product code MSW (System, Test, Thyroglobulin), a Class II device regulated under 21 CFR 866.6010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1999
Date Received
May 20, 1999
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 for product code MSW

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  • 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)
  • 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)

FDA data resources