IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ


Device Classification Name

counter, differential cell

510(k) Number K022528
Device Name IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
Original Applicant
IQ CORP.
11511 sw 127th st.
miami, 
FL 
33176

Original Contact h.g. haines
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 07/31/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No