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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Porphyrin, Spectrophotometry, Lithium
510(k) Number K243462
Device Name Diazyme Colorimetric Lithium Assay
Applicant
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92130
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92130
Correspondent Contact Abhijit Datta
Regulation Number862.3560
Classification Product Code
NDW  
Date Received11/08/2024
Decision Date 08/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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