DRI PRIMIDONE CALIBRATORS


Device Classification Name

calibrators, drug specific

510(k) Number K023780
Device Name DRI PRIMIDONE CALIBRATORS
Original Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont, 
CA 
94538

Original Contact lakshmi anne
Regulation Number 862.3200
Classification Product Code
DLJ  
Date Received 11/12/2002
Decision Date 02/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No