Cleared Traditional

ELECSYS MYOGLOBIN STAT ASSAY

K983176 · Boehringer Mannheim Corp. · Immunology
Sep 1998
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K983176 is an FDA 510(k) clearance for the ELECSYS MYOGLOBIN STAT ASSAY, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on September 24, 1998, 14 days after receiving the submission on September 10, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K983176 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1998
Decision Date September 24, 1998
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DDR — Myoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5680

Similar Devices — DDR Myoglobin, Antigen, Antiserum, Control

All 45
Access Myoglobin
K231832 · Beckman Coulter, Inc. · Sep 2023
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
K123785 · Diazyme Laboratories · Jun 2013
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · Siemens Healthcare Diagnostics, Inc. · Oct 2012
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260 · Roche Diagnostics · Oct 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
K080481 · Beckman Coulter, Inc. · Feb 2009
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · Roche Diagnostics Corp. · Jul 2006