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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Microtiter Diluting/Dispensing
510(k) Number K831462
Device Name API UNISCEPT PLUS 140 INOCULATOR
Applicant
Analytical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Analytical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2500
Classification Product Code
JTC  
Date Received05/06/1983
Decision Date 08/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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