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510(k) K855010

QUANTIMETRIC PLUS IGM REAGENT KIT by Kallestad Laboratories, Inc. — Product Code DFT

K855010 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "QUANTIMETRIC PLUS IGM REAGENT KIT". The FDA issued a decision of Substantially Equivalent on February 28, 1986. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1986
Date Received
December 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
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)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)
  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)

Other clearances for product code DFT

  • K983132 — IGM (November 4, 1998)
  • K962201 — QUANTEX IGM (September 25, 1996)
  • K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD (April 12, 1990)
  • K894417 — RAICHEM(TM) SPIA(TM) IGM REAGENTS (August 2, 1989)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K880828 — WAKO(TM) IGM-HA DIRECT (March 25, 1988)
  • K873871 — IMMUNOGLOBULINS M (October 13, 1987)
  • K872237 — KALLESTAD QM300 IGM ANTIBODY PACK (July 9, 1987)

FDA data resources