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510(k) K003057

AUTOSTAT II ENA-4 PROFILE ELISA by Cogent Diagnotics , Ltd. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2000
Date Received
October 2, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Cogent Diagnotics , Ltd.

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  • K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISA (February 3, 2000)
  • K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (February 1, 2000)
  • K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (December 6, 1999)
  • 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)
  • K992440 — AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA (September 21, 1999)

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