REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM— 510(k) K922646

Name: FDA 510(k) clearance K922646
Creator: U.S. Food and Drug Administration
Published: 1993-06-25

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K922646 for REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM, Substantially Equivalent on 1993-06-25. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1992-06-03
Decision date: 1993-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIS

view all

K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR2012-08-14
K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR2006-05-31
K060266 — DIMENSION IRON CALIBRATOR2006-03-09
K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR2005-12-23
K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)2003-11-07

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.