N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2— 510(k) K962373

Name: FDA 510(k) clearance K962373
Creator: U.S. Food and Drug Administration
Published: 1996-07-11

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K962373 for N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2, Substantially Equivalent on 1996-07-11. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1996-06-20
Decision date: 1996-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DCK

view all

K242170 — K-ASSAY CRP (Ver.2)2025-04-18
K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge2022-11-04
K192028 — Yumizen C1200 CRP2020-06-25
K192118 — CRP Vario2019-11-08
K191993 — Yumizen C1200 CRP2019-10-03

More clearances from Behring Diagnostics, Inc.

view all

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972316 — OPUS D-DIMER1997-09-09

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