MODIFICATION TO ‘RAPID DRUG SCREEN’ 9-PANEL


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K992033
Device Name MODIFICATION TO ‘RAPID DRUG SCREEN’ 9-PANEL
Applicant
AMERICAN BIO MEDICA CORP.
1001 g street, nw
suite 500w
washington, 
DC 
20001

Applicant Contact john b dubeck
Correspondent
AMERICAN BIO MEDICA CORP.
1001 g street, nw
suite 500w
washington, 
DC 
20001

Correspodent Contact john b dubeck
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJG   JXM   LAF  
LCL   LDJ   LFG  
Date Received 06/16/1999
Decision Date 06/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized