STATUS CUP ACCUSIGN CUP


Device Classification Name

reagents, test, tetrahydrocannabinol

510(k) Number K991751
Device Name STATUS CUP ACCUSIGN CUP
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 862.3870
Classification Product Code
DKE  
Subsequent Product Codes
DIO   DJG   DKZ   LAG   LCM  
Date Received 05/24/1999
Decision Date 06/18/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No