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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K981436
Device Name DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
Applicant
Casco Standards
500 Riverside Industrial Park
Portland,  ME  04103
Applicant Contact CHRISTINE V BEACH
Correspondent
Casco Standards
500 Riverside Industrial Park
Portland,  ME  04103
Correspondent Contact CHRISTINE V BEACH
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/14/1998
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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