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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K944738
Device Name SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
Applicant
Ducker CL
4507 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact KENNETH J MOSCONE
Correspondent
Ducker CL
4507 NW 103rd Ave.
Sunrise,  FL  33351
Correspondent Contact KENNETH J MOSCONE
Regulation Number862.2050
Classification Product Code
JQC  
Date Received09/26/1994
Decision Date 10/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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