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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Mycoplasma Detection
510(k) Number K860695
Device Name GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
Applicant
Gibco Laboratories Life Technologies, Inc.
P.O. Box 68
Grandisland,  NY  14072
Applicant Contact GARY J SFEIR
Correspondent
Gibco Laboratories Life Technologies, Inc.
P.O. Box 68
Grandisland,  NY  14072
Correspondent Contact GARY J SFEIR
Regulation Number864.2360
Classification Product Code
KIW  
Date Received02/25/1986
Decision Date 03/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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