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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K884693
Device Name UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
Applicant
Biomedical Research & Development Laboratories, Inc.
4301 Will Rogers Pkwy.
Suite 1000
Oklahoma City,  OK  73108
Applicant Contact SESHACHALAM DUTTA
Correspondent
Biomedical Research & Development Laboratories, Inc.
4301 Will Rogers Pkwy.
Suite 1000
Oklahoma City,  OK  73108
Correspondent Contact SESHACHALAM DUTTA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/09/1988
Decision Date 12/15/1988
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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