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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Rocky Mountain Spotted Fever
510(k) Number K843794
Device Name LATEX-R RICKETTSII
Applicant
Health Research, Inc.
1315 Empire State Plz.
Mayor Erastus Corning 2 Tower
Albany,  NY  12237
Applicant Contact ROGER S ROSENTHAL
Correspondent
Health Research, Inc.
1315 Empire State Plz.
Mayor Erastus Corning 2 Tower
Albany,  NY  12237
Correspondent Contact ROGER S ROSENTHAL
Regulation Number866.3500
Classification Product Code
GPP  
Date Received09/27/1984
Decision Date 01/04/1985
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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