Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
This device is a non-human origin blood grouping substance used in in vitro diagnostic testing to detect and characterize blood group antibodies in human serum, supporting blood bank serological investigations using antigens derived from animal sources. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSX, regulated under 21 CFR 864.9160 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSX
- Device Class
- FDA class 2
- Regulation Number
- 864.9160
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent | Gamma Biologicals, Inc. |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Nov 12, 1980 | Substantially Equivalent | Gamma Biologicals, Inc. |
| K800916 | P1 BLOOD GROUP SUBSTANCE | May 08, 1980 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K781896 | BLOOD GROUP SUBSTANCE A,B | Dec 20, 1978 | Substantially Equivalent | North American Biologicals, Inc. |
| K781895 | BLOOD GROUP SUBSTANCE B | Dec 20, 1978 | Substantially Equivalent | North American Biologicals, Inc. |
| K781862 | BLOOD GROUP SUBSTANCE A | Dec 20, 1978 | Substantially Equivalent | North American Biologicals, Inc. |
| K771488 | P1 BLOOD GROUP SUBSTANCE | Nov 08, 1977 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K771487 | LEWIS BLOOD GROUP SUBSTANCE | Nov 08, 1977 | Substantially Equivalent | Ortho Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.