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510(k) K990625

AUTOSTAT II ANTI-SM ELISA by Cogent Diagnotics , Ltd. — Product Code LKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1999
Date Received
February 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Sm 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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  • K003054 — AUTOSTAT II ENA-6 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)
  • 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)
  • K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA (November 12, 1999)
  • K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA (November 12, 1999)

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  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)