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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, neisseria
510(k) Number K991268
Device Name GONOSTAT GONOCOCCAL DETECTION KIT
Applicant
SIERRA DIAGNOSTICS
1900 K STREET, N.W.
washington,  DC  20006 -1108
Applicant Contact donald r stone
Correspondent
SIERRA DIAGNOSTICS
1900 K STREET, N.W.
washington,  DC  20006 -1108
Correspondent Contact donald r stone
Regulation Number866.3390
Classification Product Code
LSL  
Date Received04/13/1999
Decision Date 08/11/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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