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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 K920285
Device Name BLOOD GAS/ISE LINEARITY CONTROL
Applicant
Phoenix Diagnostics, Inc.
8 Tech Circle
Natick,  MA  01760
Applicant Contact RAM NUNNA
Correspondent
Phoenix Diagnostics, Inc.
8 Tech Circle
Natick,  MA  01760
Correspondent Contact RAM NUNNA
Regulation Number862.1660
Classification Product Code
JJS  
Date Received01/22/1992
Decision Date 07/14/1992
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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