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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, Mumps Virus
510(k) Number K971857
Device Name MUMPS IGG ELISA TESTY
Applicant
Gull Laboratories, Inc.
1011 Murray Holladay Rd.
Salt Lake City,  UT  84117
Applicant Contact FRED W RACHFORD
Correspondent
Gull Laboratories, Inc.
1011 Murray Holladay Rd.
Salt Lake City,  UT  84117
Correspondent Contact FRED W RACHFORD
Regulation Number866.3380
Classification Product Code
LJY  
Date Received05/20/1997
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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