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- SCEIvd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final RuleNProduct Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
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- Subpart B—Diagnostic DevicesCFR Sub-Part
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- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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DIABETES SENTRY
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- DIABETES SENTRY PRODUCTS, LLC
- Trade Name
- DIABETES SENTRY
- Generic Name
- Monitor, skin resistance/skin temperature, for insulin reactions
- Decision Date
- 7/8/1982
- Days to Decision
- 314 days
- Decision Code
- APPR
- FDA Decision
- Approval