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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bothrops Atrox Reagent
510(k) Number K843207
Device Name REPTILASE -PC
Applicant
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Applicant Contact JAMES W EICHELBERGE
Correspondent
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Correspondent Contact JAMES W EICHELBERGE
Regulation Number864.8100
Classification Product Code
JCO  
Date Received08/15/1984
Decision Date 10/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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