Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- GIRReagent, Russel Viper Venom1Product Code
- GJNFluid, Diluting, Red-Cell1Product Code
- GJPControl, Platelet2Product Code
- GJRControl, Red-Cell2Product Code
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal2Product Code
- GGJFluid, Diluting, White-Cell1Product Code
- GGKProducts, Red-Cell Lysing Products1Product Code
- GGLControl, White-Cell2Product Code
- GGMControl, Hemoglobin2Product Code
- GIFDiluent, Blood Cell1Product Code
- GLKControl, Hematocrit2Product Code
- GLQMixture, Control, White-Cell And Red-Cell Indices2Product Code
- JCFLymphocyte Separation Medium1Product Code
- JCGFluid, Diluting, Manual Cell1Product Code
- JCNControl, Cell Counter, Normal And Abnormal2Product Code
- JCOBothrops Atrox Reagent2Product Code
- JPKMixture, Hematology Quality Control2Product Code
- KRXCalibrator For Cell Indices2Product Code
- KRYCalibrator For Platelet Counting2Product Code
- KRZCalibrator For Hemoglobin And Hematocrit Measurement2Product Code
- KSACalibrator For Red-Cell And White-Cell Counting2Product Code
- MZGTest, Residual, Wbc In Leukoreduced Blood2Product Code
- NRFMaterial, Quality Control, Semen Analysis2Product Code
- NRSControl Material, Blood Circulating Epithelial Cancer Cell2Product Code
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Calibrator For Hemoglobin And Hematocrit Measurement
- Page Type
- Product Code
- Regulation Medical Specialty
- Hematology
- Review Panel
- Hematology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 864.8165
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.8165 Calibrator for hemoglobin or hematocrit measurement
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a) Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60632, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]