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510(k) K952129

ORGENTEC ANTI-TPO ELISA by American Laboratory Products Co., Ltd. — Product Code JZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
May 8, 1995
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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  • K972190 — THYROGLOBULIN ASSAY SYSTEM (July 14, 1997)
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  • 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)

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  • K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Contr (March 25, 2016)
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  • 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)