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510(k) K770566

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

K770566 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "IMMUNOELECTROPHORESIS PROFILE KIT". The FDA issued a decision of Substantially Equivalent on April 27, 1977. The device falls under product code JZS (Electrophoresis Instrumentation), a Class I device regulated under 21 CFR 866.4500. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Kallestad Laboratories, Inc.

  • K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (December 3, 1986)
  • K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT (October 22, 1986)
  • 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)
  • K855008 — QUANTIMETRIC PLUS KAPPA 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)
  • K770718 — STAIN, R-250, COOMASSIE BRILLIANT BLUE (April 26, 1977)
  • K770719 — IMMUNOELECTROFILM KIH (April 26, 1977)
  • K770150 — ELECTRO IMMUNO ASSAY KIT (February 1, 1977)

FDA data resources