EMIT 2000 GENTAMICIN PLUS ASSAY


Device Classification Name

enzyme immunoassay, gentamicin

510(k) Number K010984
Device Name EMIT 2000 GENTAMICIN PLUS ASSAY
Original Applicant
SYVA CO., DADE BEHRING, INC.
3403 yerba buena rd.
san jose, 
CA 
95135

Original Contact virginia singer
Regulation Number 862.3450
Classification Product Code
LCD  
Date Received 04/02/2001
Decision Date 04/20/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized