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510(k) K772128

FLUORESCEIN CONJUGATED by Kallestad Laboratories, Inc. — Product Code DCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
November 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fab, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5520
Review Panel
IM
Submission Type

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  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
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  • K855014 — QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (March 14, 1986)
  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855012 — QUANTIMETRIC PLUS C4 REAGENT KIT (February 26, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)

Other clearances for product code DCE

  • K781951 — ANTISERA, RHODAMINE CONJUGATED FRAGMENT (February 16, 1979)