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510(k) K072661

IMMUNOCAP THYRLOBULIN IMMUNOCAP by Phadia US, Inc. — Product Code JNL

K072661 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "IMMUNOCAP THYRLOBULIN IMMUNOCAP". The FDA issued a decision of Substantially Equivalent on November 20, 2007. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Phadia US, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2007
Date Received
September 21, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Thyroglobulin Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Phadia US, Inc.

  • K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (February 13, 2015)
  • K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GB (October 27, 2014)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (December 23, 2013)
  • K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC I (August 28, 2013)
  • K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (September 13, 2012)
  • K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (June 22, 2012)
  • DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, (February 15, 2012)
  • K111919 — IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (December 22, 2011)
  • K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (September 30, 2011)

Other clearances for product code JNL

  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K240996 — Access Thyroglobulin Antibody II (July 3, 2024)
  • K112933 — ACCESS THYROGLOBULIN ANITBODY (December 27, 2011)
  • K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALI (October 5, 2006)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K962451 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (November 25, 1996)
  • K962341 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (November 25, 1996)
  • K954256 — ANTI-TPO (November 27, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)

FDA data resources