Anesthesiology
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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
- KISSera, Animal And Human1Product Code
- KITMedia And Components, Synthetic Cell And Tissue Culture1Product Code
- K892938AMNIO-GROW TM1Cleared 510(K)
- K890701ENDOTHELIAL GROWTH MEDIUM (EGM)1Cleared 510(K)
- K890700MELANOCYTE GROWTH MEDIUM (MGM)1Cleared 510(K)
- K890482ABC, ABC-1X, ABC(TM)1Cleared 510(K)
- K884654ALPHACALF SERUM1Cleared 510(K)
- K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D97851Cleared 510(K)
- K884573HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H48911Cleared 510(K)
- K884572RPMI-1640 HYBRI-MAX, PROD. NO. R53821Cleared 510(K)
- K883065ALLOPREP SYSTEM1Cleared 510(K)
- K884031FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT1Cleared 510(K)
Show All 367 Submissions
- 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
- Physical MedicineReview Panel
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- UnknownReview Panel
ALLOPREP SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K883065
- 510(k) Type
- Traditional
- Applicant
- OSTEOTECH, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/13/1988
- Days to Decision
- 85 days