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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K942250
Device Name BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER
Applicant
BIOWHITTAKER MOLECULAR APPLICATIONS, INC.
8830 BIGGS FORD RD.
WALKERSVILLE,  MD  21793 -0127
Applicant Contact LEIF E OLSEN
Correspondent
BIOWHITTAKER MOLECULAR APPLICATIONS, INC.
8830 BIGGS FORD RD.
WALKERSVILLE,  MD  21793 -0127
Correspondent Contact LEIF E OLSEN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received05/09/1994
Decision Date 04/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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