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510(k) K781951

ANTISERA, RHODAMINE CONJUGATED FRAGMENT by Kallestad Laboratories, Inc. — Product Code DCE

K781951 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "ANTISERA, RHODAMINE CONJUGATED FRAGMENT". The FDA issued a decision of Substantially Equivalent on February 16, 1979. The device falls under product code DCE (Fab, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1979
Date Received
November 21, 1978
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

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)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)

Other clearances for product code DCE

  • K772128 — FLUORESCEIN CONJUGATED (November 22, 1977)

FDA data resources