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510(k) K991942

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA by Cogent Diagnotics , Ltd. — Product Code MLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1999
Date Received
June 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device Class
Class II
Regulation Number
866.5110
Review Panel
IM
Submission Type

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  • K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (February 1, 2000)
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  • K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA (November 12, 1999)
  • K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA (November 12, 1999)

Other clearances for product code MLE

  • K010558 — QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (April 3, 2001)
  • K951206 — VARELISA PARIETAL CELL ANTIBODIES (April 17, 1995)