KALLESTAD SSA/SSB ENA TEST REAGENTS— 510(k) K862710

Name: FDA 510(k) clearance K862710
Creator: U.S. Food and Drug Administration
Published: 1986-07-29

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K862710 for KALLESTAD SSA/SSB ENA TEST REAGENTS, Substantially Equivalent on 1986-07-29. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1986-07-16
Decision date: 1986-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

view all

K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La2026-08-21
K253367 — EliA CTD 13 Screen2026-06-25
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K213403 — Aptiva CTD Essential Reagent2023-09-29

More clearances from Kallestad Laboratories, Inc.

view all

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

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