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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
510(k) Number K900819
Device Name BLOOD GAS CALIBRATION STANDARD
Applicant
Cryogenic Rare Gas Laboratories, Inc.
913 Commerce Cir.
Hanahan,  SC  29410
Applicant Contact KENNETH DINICOLA
Correspondent
Cryogenic Rare Gas Laboratories, Inc.
913 Commerce Cir.
Hanahan,  SC  29410
Correspondent Contact KENNETH DINICOLA
Regulation Number862.1660
Classification Product Code
LCH  
Date Received02/21/1990
Decision Date 04/25/1990
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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