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510(k) K820368

LECTIN-A by American Dade — Product Code KSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
February 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lectins And Protectins
Device Class
Class II
Regulation Number
864.9550
Review Panel
HE
Submission Type

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  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code KSI

  • K813413 — LECTIN H (March 4, 1982)
  • K792583 — GAMMA ARACHIS HYPOGEA LECTIN (January 16, 1980)
  • K792582 — POLY-LEC SYSTEM (January 16, 1980)