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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
510(k) Number K891990
Device Name RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
Applicant
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Applicant Contact HELEN SCHNEIDER
Correspondent
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Correspondent Contact HELEN SCHNEIDER
Regulation Number866.3520
Classification Product Code
LJB  
Date Received03/28/1989
Decision Date 06/15/1989
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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