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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K945245
Device Name BLOOD KIT, SEXUAL ASSAULT KIT
Applicant
Lynn Peavey Co.
14865 W. 105th St.
Lenexa,  KS  66215
Applicant Contact PAUL SCHILLING
Correspondent
Lynn Peavey Co.
14865 W. 105th St.
Lenexa,  KS  66215
Correspondent Contact PAUL SCHILLING
Regulation Number862.1675
Classification Product Code
JKA  
Date Received10/27/1994
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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