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510(k) K011201

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2001
Date Received
April 19, 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

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  • 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)
  • K962052 — ORGENTEC ABTI-SS-BB(LA) ELISA (November 15, 1996)
  • K962055 — ORGENTEC ANTI-SCL 70 ELISA (November 15, 1996)

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  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)