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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric, Cortisol
510(k) Number K863422
Device Name DELFIA(TM) CORTISOL KIT
Applicant
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Applicant Contact ED ZIOR
Correspondent
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Correspondent Contact ED ZIOR
Regulation Number862.1205
Classification Product Code
JFT  
Date Received09/04/1986
Decision Date 09/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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