FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES— 510(k) K873708

Name: FDA 510(k) clearance K873708
Creator: U.S. Food and Drug Administration
Published: 1987-11-25

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K873708 for FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES, Substantially Equivalent on 1987-11-25. Applicant: Whittaker Bioproducts, Inc.. Device class: 2.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-09-15
Decision date: 1987-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, 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 Whittaker Bioproducts, Inc.

view all

K911356 — LEGIONELLA STAT IGG/IGM TEST KIT1992-07-30
K913212 — 3M IGE SINGLE POINT FAST TEST1991-11-22
K904652 — LYME STAT M TEST KIT1991-10-21
K904893 — FIAX LYME M TEST KIT1991-10-16
K911473 — EBNA STAT TEST KIT1991-09-25

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