ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K992397
Device Name ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
Applicant
CENOGENICS CORP.
100 rt. 520
morganville, 
NJ 
07751

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

Correspodent Contact nitza katz
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 07/19/1999
Decision Date 08/26/1999
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