TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001


Device Classification Name

radioimmunoassay, thyroid-stimulating hormone

510(k) Number K991146
Device Name TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
Applicant
BIOCHECK, INC.
9418 lasaine ave.
northridge, 
CA 
91325

Applicant Contact robin j hellen
Correspondent
BIOCHECK, INC.
9418 lasaine ave.
northridge, 
CA 
91325

Correspodent Contact robin j hellen
Regulation Number 862.1690
Classification Product Code
JLW  
Date Received 04/05/1999
Decision Date 06/22/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No