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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- KIPFormulations, Balanced Salt Solutions1Product Code
- KIQKit, Culture, Chromosome1Product Code
- KIRCells, Animal And Human, Cultured1Product Code
- K973214FRESH CELLS HFF1Cleared 510(K)
- K973211FRESH CELLS MV1LU1Cleared 510(K)
- K973212FRESH CELLS WI-381Cleared 510(K)
- K973210FRESH CELLS NCI H2921Cleared 510(K)
- K973213FRESH CELLS LLC-MK21Cleared 510(K)
- K973209FRESH CELLS VERO1Cleared 510(K)
- K971508RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE1Cleared 510(K)
- K972414FRESHCELLS1Cleared 510(K)
- K965047MINK LUNG CELL CULTURE1Cleared 510(K)
- K962780FRESHCELLS, HEP-21Cleared 510(K)
Show All 170 Submissions
- KISSera, Animal And Human1Product Code
- KITMedia And Components, Synthetic Cell And Tissue Culture1Product Code
- KIWKit, Mycoplasma Detection1Product Code
- KIXMedia, Mycoplasma Detection1Product Code
- KIYChamber, Slide Culture1Product Code
- KIZDish, Tissue Culture1Product Code
- KJAFlask, Tissue Culture1Product Code
- KJBApparatus, Roller1Product Code
- KJCBottle, Roller, Tissue Culture1Product Code
- KJDSpinner, Flask1Product Code
- KJESpinner System, Cell Culture1Product Code
- KJFSystem, Suspension, Cell Culture1Product Code
- KJHApparatus, Perfusion1Product Code
- KPBMedia And Components, Mycoplasma Detection1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K971508
- 510(k) Type
- Traditional
- Applicant
- BIO-WHITTAKER, INC., A CAMBREX CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/17/1997
- Days to Decision
- 145 days
- Submission Type
- Summary