IRISPEC,CA/CB/CC


Device Classification Name

urinalysis controls (assayed and unassayed)

510(k) Number K072640
Device Name IRISPEC,CA/CB/CC
Applicant
IRIS DIAGNOSTICS
9172 eton ave.
chatsworth, 
CA 
91311

Applicant Contact gerald haddock
Correspondent
IRIS DIAGNOSTICS
9172 eton ave.
chatsworth, 
CA 
91311

Correspodent Contact gerald haddock
Regulation Number 862.1660
Classification Product Code
JJW  
Date Received 09/18/2007
Decision Date 12/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No