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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 K942245
Device Name BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE
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 04/03/1995
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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