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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, Rubella
510(k) Number K921573
Device Name RUBELLA IGM
Applicant
Clark Laboratories, Inc.
53 Cedar Lake Rd.
Blairstown,  NJ  07825
Applicant Contact Gary Lehnus
Correspondent
Clark Laboratories, Inc.
53 Cedar Lake Rd.
Blairstown,  NJ  07825
Correspondent Contact Gary Lehnus
Regulation Number866.3510
Classification Product Code
LFX  
Date Received04/02/1992
Decision Date 08/27/1992
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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