BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117


Device Classification Name

amplifier and signal conditioner, biopotential

510(k) Number K022660
Device Name BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
Original Applicant
BIOCHECK, INC.
9418 lasaine ave.
northridge, 
CA 
91325

Original Contact robin j hellen
Regulation Number 870.2050
Classification Product Code
DRR  
Date Received 08/09/2002
Decision Date 12/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No