MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)— 510(k) K962344

Name: FDA 510(k) clearance K962344
Creator: U.S. Food and Drug Administration
Published: 1996-08-15

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K962344 for MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1996-08-15. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 1996-06-18
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDR

view all

K231832 — Access Myoglobin2023-09-18
K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET2013-06-07
K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR2012-10-03
K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN2009-10-16
K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS2009-02-20

More clearances from Bayer Corp.

view all

K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER2003-03-03
K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST2003-02-11
K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY2003-01-30
K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL2003-01-23
K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM2002-12-17

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