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510(k) K770719

IMMUNOELECTROFILM KIH by Kallestad Laboratories, Inc. — Product Code JZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1977
Date Received
April 18, 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

Other clearances by Kallestad Laboratories, Inc.

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  • K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT (October 10, 1986)
  • K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (September 29, 1986)
  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
  • K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS (July 29, 1986)
  • 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 JZS

  • K933123 — SYNELISA TG ANTIBODIES/TPO ANTIBODIES (August 23, 1993)
  • K812194 — IMMUNODIFFUSION BAND INTENSIFYING FLUID (August 31, 1981)
  • K770566 — IMMUNOELECTROPHORESIS PROFILE KIT (April 27, 1977)
  • K770718 — STAIN, R-250, COOMASSIE BRILLIANT BLUE (April 26, 1977)
  • K770150 — ELECTRO IMMUNO ASSAY KIT (February 1, 1977)