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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K781421
Device Name BIOSCAN E12
Applicant
Clinifax Industries, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Clinifax Industries, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJS  
Date Received08/17/1978
Decision Date 09/20/1978
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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