PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM— 510(k) K863681

Name: FDA 510(k) clearance K863681
Creator: U.S. Food and Drug Administration
Published: 1986-12-03

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K863681 for PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM, Substantially Equivalent on 1986-12-03. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1986-09-19
Decision date: 1986-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT1986-10-22
K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT1986-10-10
K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS1986-09-29
K862313 — KALLESTAD SM/RNP TEST REAGENT1986-08-06
K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS1986-07-29

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