PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS— 510(k) K853554

Name: FDA 510(k) clearance K853554
Creator: U.S. Food and Drug Administration
Published: 1985-11-26

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K853554 for PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS, Substantially Equivalent on 1985-11-26. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1985-08-26
Decision date: 1985-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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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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K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT1986-10-10
K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS1986-09-29
K862313 — KALLESTAD SM/RNP TEST REAGENT1986-08-06

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