Test, Leukocyte Typing
A leukocyte typing test is a hematology laboratory reagent or device used to identify and characterize the surface antigens on white blood cells, supporting histocompatibility testing, organ transplantation matching, and immunological research. The device is FDA Class 1, the lowest risk category, requiring only general controls without premarket notification. It carries product code LGO and is regulated under 21 CFR 864.7675 within the Hematology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LGO
- Device Class
- FDA class 1
- Regulation Number
- 864.7675
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894947 | PLATELIA TOXO IGG KIT | Mar 23, 1990 | Substantially Equivalent | Kallestad Diag, A Div. of Erbamont, Inc. |
| K874544 | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT | Aug 12, 1988 | Substantially Equivalent | Molecular Biosystems, Inc. |
| K791118 | HLA CONTROL SERA | Aug 03, 1979 | Substantially Equivalent | Calbiochem-Behring Corp. |
| K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL | Apr 06, 1977 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
| K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL | Apr 06, 1977 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.