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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 K812787
Device Name EIA RUBELLA
Applicant
GILFORD
803 n. front st. suite 3
mchenry,  IL  60050
Correspondent
GILFORD
803 n. front st. suite 3
mchenry,  IL  60050
Regulation Number866.3510
Classification Product Code
LFX  
Date Received10/05/1981
Decision Date 11/27/1981
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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