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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K934146
Device Name N-ASSAY TIA MICROALBUMIN
Applicant
Crestat Diagnostics, Inc.
822 Hampshire Rd.
Unit C
Thousand Oaks,  CA  91361
Applicant Contact MARY REES
Correspondent
Crestat Diagnostics, Inc.
822 Hampshire Rd.
Unit C
Thousand Oaks,  CA  91361
Correspondent Contact MARY REES
Regulation Number862.1645
Classification Product Code
JIR  
Date Received08/24/1993
Decision Date 01/11/1994
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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