BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K023944
Device Name BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
Original Applicant
BAYER CORP.
63 north st.
medfield, 
MA 
02052 -1688

Original Contact thomas f flynn
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 11/26/2002
Decision Date 02/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No