PATHFINDER ROTAVIRUS CHEMILUMINESCENT— 510(k) K862917

Name: FDA 510(k) clearance K862917
Creator: U.S. Food and Drug Administration
Published: 1986-10-22

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K862917 for PATHFINDER ROTAVIRUS CHEMILUMINESCENT, Substantially Equivalent on 1986-10-22. 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: 1986-08-01
Decision date: 1986-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIQ

view all

K990842 — SAS ROTA TEST1999-08-09
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K971585 — IMMUNOCARD STAT! ROTAVIRUS1997-08-20
K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05

More clearances from Kallestad Laboratories, Inc.

view all

K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM1986-12-03
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

Data sourced from openFDA. This site is unofficial and independent of the FDA.