Kit, Quality Control For Blood Banking Reagents
This device is a quality control kit for blood banking reagents, used to verify the performance and accuracy of serological reagents and test systems used in blood grouping, antibody detection, and compatibility testing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSF, regulated under 21 CFR 864.9650 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSF
- Device Class
- FDA class 2
- Regulation Number
- 864.9650
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K811713 | AVI-D CONTROL | Oct 23, 1981 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K810599 | DADE RH CONTROL REAGENT | Mar 31, 1981 | Substantially Equivalent | American Dade |
| K801425 | RH CONTROL | Jul 14, 1980 | Substantially Equivalent | North American Biologicals, Inc. |
| K800658 | RST-SERIES CONTROL | Apr 16, 1980 | Substantially Equivalent | Gamma Biologicals, Inc. |
| K800310 | ORTHO ANTISERA CONTROL | Mar 05, 1980 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K800239 | RH-HR NEGATIVE CONTROL REAGENT | Feb 21, 1980 | Substantially Equivalent | Gotham Biologics, Inc. |
| K790249 | TEST CELLS | May 16, 1979 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
| K790025 | COUNTER CHECK, H001, H002, H003 | Jan 17, 1979 | Substantially Equivalent | Diagnostic Technology, Inc. |
| K780665 | RECAP | Jun 06, 1978 | Substantially Equivalent | Bca Biological Corp. of America |
| K780097 | QUALITY CONTROL SYSTEM, SPECTRA | Apr 24, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K771814 | REAGENT CONFIDENCE SERA | Nov 07, 1977 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K761284 | UNIVAL CONTROL CELLS | Jan 25, 1977 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.