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510(k) K991890

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA by Cogent Diagnotics , Ltd. — Product Code MVJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1999
Date Received
June 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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  • K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (February 1, 2000)
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  • K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (November 24, 1999)
  • 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 MVJ

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  • K984619 — BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (February 23, 1999)
  • K984336 — QUANTA LITE GBM ELISA (February 8, 1999)