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510(k) K981559

UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY by Pharmacia & Upjohn Co. — Product Code JZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1998
Date Received
May 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

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  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)
  • K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16 (February 18, 2000)
  • K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396 (January 5, 2000)
  • K993388 — ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F (December 1, 1999)
  • K993589 — VARELISA RNP ANTIBODIES (November 26, 1999)
  • K993109 — VARELISA RECOMBI ANA PROFILE (November 12, 1999)
  • K993108 — VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (November 12, 1999)
  • K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 (July 28, 1999)

Other clearances for product code JZO

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  • K240469 — Access TPO Antibody (August 9, 2024)
  • K213517 — Access Thyroglobulin Antibody II (September 26, 2023)
  • K222610 — Elecsys Anti-Tg (September 15, 2023)
  • K193313 — Elecsys Anti-TSHR (February 27, 2020)
  • K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Contr (March 25, 2016)
  • K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (March 3, 2016)
  • K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
  • K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 (September 3, 2009)
  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)