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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K832648
Device Name ACCLAIM
Applicant
Electro-Nucleonics Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Electro-Nucleonics Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/05/1983
Decision Date 09/20/1983
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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