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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K001632
Device Name OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
Applicant
AVL SCIENTIFIC CORP.
235 HEMBREE PARK DR.
ROSWELL,  GA  30076
Applicant Contact RANDY BYRD
Correspondent
AVL SCIENTIFIC CORP.
235 HEMBREE PARK DR.
ROSWELL,  GA  30076
Correspondent Contact RANDY BYRD
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/26/2000
Decision Date 06/19/2000
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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