PATHFINDER(TM) SPECIMEN COLLECTION KIT— 510(k) K863682

Name: FDA 510(k) clearance K863682
Creator: U.S. Food and Drug Administration
Published: 1986-10-10

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K863682 for PATHFINDER(TM) SPECIMEN COLLECTION KIT, Substantially Equivalent on 1986-10-10. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1986-09-19
Decision date: 1986-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kallestad Laboratories, Inc.

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K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM1986-12-03
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K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS1986-09-29
K862313 — KALLESTAD SM/RNP TEST REAGENT1986-08-06
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