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510(k) K011415

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

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.

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  • 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)
  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962052 — ORGENTEC ABTI-SS-BB(LA) ELISA (November 15, 1996)
  • K962055 — ORGENTEC ANTI-SCL 70 ELISA (November 15, 1996)

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  • 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)