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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K972309
Device Name JM-102 JAUNDICE METER
Applicant
Air-Shields, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
Air-Shields, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number862.1113
Classification Product Code
MQM  
Date Received06/20/1997
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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