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510(k) K994338

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA by Cogent Diagnotics , Ltd. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2000
Date Received
December 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by Cogent Diagnotics , Ltd.

  • K003054 — AUTOSTAT II ENA-6 PROFILE ELISA (October 13, 2000)
  • K003057 — AUTOSTAT II ENA-4 PROFILE ELISA (October 13, 2000)
  • K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (September 28, 2000)
  • K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (March 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)
  • K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA (November 12, 1999)
  • K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA (November 12, 1999)
  • K992440 — AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA (September 21, 1999)

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