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510(k) K011415

ALPCO MILENIA ANTI-TG EIA by American Laboratory Products Co., Ltd. — Product Code JZO

K011415 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "ALPCO MILENIA ANTI-TG EIA". The FDA issued a decision of Substantially Equivalent on May 30, 2001. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2001
Date Received
May 8, 2001
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

Other clearances by American Laboratory Products Co., Ltd.

  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K011201 — ALPCO MILENIA ANTI-TPO ELISA (May 24, 2001)
  • K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA (February 17, 1998)
  • K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA (February 17, 1998)
  • K972190 — THYROGLOBULIN ASSAY SYSTEM (July 14, 1997)
  • K970932 — ORGENTEC MICRO-ALBUMIN EIA ASSAY (April 8, 1997)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962055 — ORGENTEC ANTI-SCL 70 ELISA (November 15, 1996)
  • K962054 — ORGENTEC ANTI-SS-A(RO) ELISA (November 15, 1996)

Other clearances for product code JZO

  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • 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)

FDA data resources