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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, lsd (125-i)
510(k) Number K891167
Device Name COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles,  CA  90045 -5597
Original Contact kenneth b asarch
Regulation Number862.3580
Classification Product Code
DLB  
Date Received03/06/1989
Decision Date 05/03/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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