BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K991741
Device Name BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
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 862.1155
Classification Product Code
JHI  
Date Received 05/21/1999
Decision Date 07/22/1999
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