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510(k) K813413

LECTIN H by American Dade — Product Code KSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
December 7, 1981
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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  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code KSI

  • K820368 — LECTIN-A (April 14, 1982)
  • K792583 — GAMMA ARACHIS HYPOGEA LECTIN (January 16, 1980)
  • K792582 — POLY-LEC SYSTEM (January 16, 1980)