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510(k) K891683

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER by Helena Laboratories — Product Code CZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1989
Date Received
March 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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Other clearances for product code CZN

  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)
  • K841815 — OPTIMATE IGA TEST (June 1, 1984)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832257 — GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (October 28, 1983)
  • K831909 — RABBIT ANTISERUM TO HUMAN IGA (July 18, 1983)
  • K831607 — FIAX IGA TEST KIT (June 22, 1983)