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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 K870115
Device Name BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS
Applicant
Berthold Analytical Instruments, Inc.
28 Charron Ave.
Nashua,  NH  03063
Applicant Contact MAX E TYRRELL
Correspondent
Berthold Analytical Instruments, Inc.
28 Charron Ave.
Nashua,  NH  03063
Correspondent Contact MAX E TYRRELL
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received01/12/1987
Decision Date 03/31/1987
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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