Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- IERPolyethylene Glycol (Carbowax)1Product Code
- IEXGelatin1Product Code
- IEZCelloidin1Product Code
- HZIAcid, Osmic1Product Code
- IALIodine (Tincture)1Product Code
- IAMSolution, Lugol'S1Product Code
- IATSyrup, Gum, Apathy'S1Product Code
- IAWCollodion1Product Code
- IAYColchicine1Product Code
- IBAStreptolysin O1Product Code
- IBCDiastase1Product Code
- IBDHyaluronidase1Product Code
- IBENeuramininase (Sialidase)1Product Code
- IBFPapain1Product Code
- IBGTrypsin1Product Code
- IFFSolution, Decalcifier, Electrolytic1Product Code
- IFHSolution, Zenker'S1Product Code
- IFISprays, Synthetic, Smear1Product Code
- IFJFixative, Richardson Glycol1Product Code
- IFLPolyethylene Glycol Preservative1Product Code
- IFNSolution, Orth'S1Product Code
- IFPFormalin, Neutral Buffered1Product Code
- IFQFormulations, Mercuric Chloride For Tissue1Product Code
- IFTGlutaraldehyde1Product Code
- IFYGelatin-Formalin1Product Code
- IFZGelatin For Specimen Adhesion1Product Code
- IGBSolution, Formalin-Sodium Acetate1Product Code
- IGCFormalin-Saline1Product Code
- IGDSolution, Formol Calcium1Product Code
- IGESolution, Formalin Ammonium Bromide1Product Code
- IGFSolution, Formalin-Alcohol-Acetic Acid1Product Code
- IGGFormaldehyde (Formalin, Formol)1Product Code
- IGMSolution, Carnoy'S1Product Code
- IGNFluid, Bouin'S1Product Code
- JCBDetergent1Product Code
- JCCPh Buffer1Product Code
- JCESolution, Isotonic1Product Code
- KDXSolution, Decalcifier, Acid Containing1Product Code
- KDYAgent, Chelating For Decalcification1Product Code
- KEEOsmium Tetroxide1Product Code
- KELAdhesive, Albumin-Based1Product Code
- KEMAgent, Clearing1Product Code
- KEOFormulations, Paraffin, All1Product Code
- KEPMedia, Mounting, Oil Soluble1Product Code
- KEQMedia, Mounting, Water Soluble1Product Code
- LDWFixative, Acid Containing1Product Code
- LDXFixative, Metallic Containing1Product Code
- LDYFixative, Formalin-Containing1Product Code
- LDZFixative, Alcohol Containing1Product Code
- LEAPreservative, Cytological1Product Code
- LEBMounting Media1Product Code
- LIJPeroxidase Anti-Peroxidase Immunohistochemical Stain1Product Code
- PPMGeneral Purpose Reagent1Product Code
- 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
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K855034
- 510(k) Type
- Traditional
- Applicant
- BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/11/1986
- Days to Decision
- 84 days