ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K030533
Device Name ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
Applicant
CENOGENICS CORP.
100 rt. 520
morganville, 
NJ 
07751

Applicant Contact nitz katz
Correspondent
CENOGENICS CORP.
100 rt. 520
morganville, 
NJ 
07751

Correspodent Contact nitz katz
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 02/14/2003
Decision Date 04/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No