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- OTVResearch Use Only/Clinical Chemistry DevicesNProduct Code
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- PDAInvestigational Use Only - Clinical ChemistryNProduct Code
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- SCHLdt, Approved By Nys ClepNProduct Code
- SCEIvd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCFLdt, Unmet Need Within An Integrated Healthcare SystemNProduct Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- 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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SALEST TM SYSTEM
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- HOLOGIC, INC.
- Trade Name
- SALEST TM SYSTEM
- Generic Name
- salivary estriol test
- Decision Date
- 4/29/1998
- Days to Decision
- 287 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval