Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- 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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ABBOTT ER-ICA MONOCLONAL
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Laboratories
- Trade Name
- ABBOTT ER-ICA MONOCLONAL
- Generic Name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Decision Date
- 9/30/1988
- Days to Decision
- 179 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval