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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K862206
Device Name TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
Applicant
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact DEBORAH L LINDEMUTH
Correspondent
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact DEBORAH L LINDEMUTH
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received06/10/1986
Decision Date 08/04/1986
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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