ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K992422
Device Name ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000
Applicant
PRINCETON BIOMEDITECH CORP.
4242 u.s. rt. 1
monmouth junction, 
NJ 
08852 -1905

Applicant Contact jemo kang
Correspondent
PRINCETON BIOMEDITECH CORP.
4242 u.s. rt. 1
monmouth junction, 
NJ 
08852 -1905

Correspodent Contact jemo kang
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 07/21/1999
Decision Date 08/10/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No