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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, Centrifugal, For Clinical Use
510(k) Number K811525
Device Name FLEXIGRAM AUTO LOADER SYSTEM
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 Number862.2140
Classification Product Code
JJG  
Date Received05/29/1981
Decision Date 06/18/1981
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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