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510(k) K770566

IMMUNOELECTROPHORESIS PROFILE KIT by Kallestad Laboratories, Inc. — Product Code JZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1977
Date Received
March 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoresis Instrumentation
Device Class
Class I
Regulation Number
866.4500
Review Panel
IM
Submission Type

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  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855012 — QUANTIMETRIC PLUS C4 REAGENT KIT (February 26, 1986)
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