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- 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)
- K902997MILENIA (TM) FERRITIN2Cleared 510(K)
- K890697RIA-GNOST FERRITIN2Cleared 510(K)
- K881138CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.2Cleared 510(K)
- K873730MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT2Cleared 510(K)
- K872955DELFIA(TM) FERRITIN KIT2Cleared 510(K)
- K840460CORNINGS MAGIC FERRITIN RADIOIMMUNO-2Cleared 510(K)
- K810799QUANTIMUNE FERRITIN IRMA2Cleared 510(K)
- K792588TERRITIN RIA KIT2Cleared 510(K)
- K791096RADIOIMMUNOASSAY TEST SYSTEM2Cleared 510(K)
- K782157IRMA TEST, NORDICLAB FERRITIN2Cleared 510(K)
- K781946RIA KIT, FERRITIN SOLID PHASE2Cleared 510(K)
- K781888ASSAY SYSTEM, FERRITIN I KIT2Cleared 510(K)
- K781844FERRITIN KIT2Cleared 510(K)
- K781527RIA SYSTEM FOR HUMAN FE-RITIN2Cleared 510(K)
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IRMA TEST, NORDICLAB FERRITIN
- Page Type
- Cleared 510(K)
- 510(k) Number
- K782157
- 510(k) Type
- Traditional
- Applicant
- NORDICLAB INTL.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/1979
- Days to Decision
- 26 days