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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 K885082
Device Name IMMUNODOT RUBELLA TEST
Applicant
General Biometrics, Inc.
11199 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact E. F WADDELL
Correspondent
General Biometrics, Inc.
11199 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact E. F WADDELL
Regulation Number866.3510
Classification Product Code
LFX  
Date Received12/09/1988
Decision Date 02/02/1989
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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