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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometer, Clinical Use
510(k) Number K810938
Device Name MASS SPECTROMETER-MEDSPECT II
Applicant
Allied Healthcare Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Allied Healthcare Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2860
Classification Product Code
DOP  
Date Received04/07/1981
Decision Date 04/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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