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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 K884898
Device Name IMMUNODOT TORCH TEST RUBELLA
Applicant
General Biometrics, Inc.
11199 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact EDWARD F WADDELL
Correspondent
General Biometrics, Inc.
11199 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact EDWARD F WADDELL
Regulation Number866.3510
Classification Product Code
LFX  
Date Received11/23/1988
Decision Date 02/03/1989
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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