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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 K871184
Device Name FLAME PHOTOMETER STANDARD #60083 160 NA/8K
Applicant
In Vitro Diagnostics, Inc.
415 Howe Ave.
Shelton,  CT  06484
Applicant Contact JAY MININBERG
Correspondent
In Vitro Diagnostics, Inc.
415 Howe Ave.
Shelton,  CT  06484
Correspondent Contact JAY MININBERG
Regulation Number862.1150
Classification Product Code
JIX  
Date Received03/24/1987
Decision Date 05/28/1987
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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