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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, Mycoplasma Spp.
510(k) Number K963054
Device Name IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
Applicant
Genbio
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact Bryan Kiehl
Correspondent
Genbio
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact Bryan Kiehl
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received08/06/1996
Decision Date 05/05/1997
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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