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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All, Mycoplasma Spp.
510(k) Number K931557
Device Name FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
Applicant
Fuller Laboratories, Inc.
2478 E. Fender, Unit 1
Fullerton,  CA  92631
Applicant Contact LEE FULLER
Correspondent
Fuller Laboratories, Inc.
2478 E. Fender, Unit 1
Fullerton,  CA  92631
Correspondent Contact LEE FULLER
Regulation Number866.3375
Classification Product Code
GRZ  
Date Received03/30/1993
Decision Date 03/11/1994
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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