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U.S. Department of Health and Human Services

Product Classification
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Device investigational use only - clinical chemistry
Definition Investigational use only and for products imported into the US only.
Physical State N/A
Technical Method N/A
Target Area N/A
Review Panel Clinical Chemistry
Product CodePDA
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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