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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, General Purpose, Microbiology, Diagnostic
510(k) Number K832117
Device Name IMMULON SUBSTRATE REMOVAWELL STRIPS
Applicant
Dynatech Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dynatech Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2660
Classification Product Code
LIB  
Date Received06/30/1983
Decision Date 08/08/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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