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510(k) K852125

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP by Kallestad Laboratories, Inc. — Product Code GQL

K852125 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP". The FDA issued a decision of Substantially Equivalent on July 30, 1985. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1985
Date Received
May 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
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 GQL

  • K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
  • K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (April 1, 2009)
  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (May 26, 1999)
  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K904167 — PATHODX HERPES TYPING (December 13, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)

FDA data resources