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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K926569
Device Name IMMUNO RA UNDILUTED
Applicant
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact KUPITS
Correspondent
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact KUPITS
Regulation Number866.5775
Classification Product Code
DHR  
Date Received12/31/1992
Decision Date 04/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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