Home / 510(k) Clearances / K863682

510(k) K863682

PATHFINDER(TM) SPECIMEN COLLECTION KIT by Kallestad Laboratories, Inc. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1986
Date Received
September 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
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)
  • 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)
  • K855008 — QUANTIMETRIC PLUS KAPPA REAGENT KIT (February 26, 1986)

Other clearances for product code JSM

  • K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport De (November 26, 2025)
  • K250205 — Babio® Virus Transport Kit (Non-inactivating) (September 22, 2025)
  • K242576 — AllTest Viral Transport Medium (April 4, 2025)
  • K232565 — UriSponge™ (October 11, 2024)
  • K220908 — Ensol EnTM Specimen Collection and Transport System (August 29, 2024)
  • K240235 — OmniTrans Transport System (August 19, 2024)
  • K233534 — Viral Transport Medium (August 2, 2024)
  • K233449 — Avantik VTM (July 15, 2024)
  • K232454 — Viral Transport Media (VTM) (May 3, 2024)
  • K232357 — Copan Universal Transport Medium (UTM-RT) System (April 25, 2024)