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
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin2Product Code
- K234052Access Ferritin2Cleared 510(K)
- K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 330202Cleared 510(K)
- K964282TINA-QUANT FERRITIN ASSAY2Cleared 510(K)
- K971833ELECSYS FERRITIN2Cleared 510(K)
- K963498FERR FLEX REAGENT CARTRIDGE2Cleared 510(K)
- K950393ACE(TM) CEDIA(R) FERRITIN ASSAY2Cleared 510(K)
- K926221ACCESS FERRITIN ASSAY2Cleared 510(K)
- K925848IMMULITE FERRITIN2Cleared 510(K)
- K920829COBAS CORE FERRITIN EIA2Cleared 510(K)
- K920318CEDIA FERRITIN ASSAY2Cleared 510(K)
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FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K052082
- 510(k) Type
- Special
- Applicant
- BECKMAN COULTER, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/19/2005
- Days to Decision
- 17 days
- Submission Type
- Summary