Solution, Stabilized Enzyme
This device is a stabilized enzyme solution used in blood bank immunohematology to treat red blood cells, enhancing or diminishing the reactivity of certain blood group antigens to facilitate antibody identification and compatibility testing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSK, regulated under 21 CFR 864.9400 within the Hematology specialty. No special flags apply.
Research product code KSK in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KSK
- Device Class
- FDA class 2
- Regulation Number
- 864.9400
- 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 |
|---|---|---|---|---|
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Mar 04, 1982 | Substantially Equivalent | Gamma Biologicals, Inc. |
| K813404 | FREEZE DRIED FICIN | Feb 10, 1982 | Substantially Equivalent | Biological Corp. of America |
| K810803 | FREEZE DRIED PAPAIN | Jul 21, 1981 | Substantially Equivalent | Biological Corp. of America |
| K780962 | AUTOMATED ENZYME | Jul 27, 1978 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
| K760123 | AUTOZYME | Jul 20, 1976 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.