IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25


Device Classification Name

indicator method, protein or albumin (urinary, non-quant.)

510(k) Number K022538
Device Name IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
Original Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
26371 eva st.
laguna hills, 
CA 
92656

Original Contact mike berg
Regulation Number 862.1645
Classification Product Code
JIR  
Date Received 08/01/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No