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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 K841783
Device Name BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
Applicant
BIONOSTICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIONOSTICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1660
Classification Product Code
JJS  
Date Received04/30/1984
Decision Date 06/14/1984
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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