Home / 510(k) Clearances / K772345

510(k) K772345

FLUORESCEIN CONJUG. FRACT. MONO. ANTI. by Kallestad Laboratories, Inc. — Product Code DCB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1978
Date Received
December 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fab, Fitc, 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)
  • K855012 — QUANTIMETRIC PLUS C4 REAGENT KIT (February 26, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)