Lectins And Protectins
This device consists of lectins and protectins, which are biological substances derived from plants or animals used in blood banking to detect specific blood group antigens and resolve complex serological problems during blood typing and antibody investigation. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSI, regulated under 21 CFR 864.9550 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSI
- Device Class
- FDA class 2
- Regulation Number
- 864.9550
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K820368 | LECTIN-A | Apr 14, 1982 | Substantially Equivalent | American Dade |
| K813413 | LECTIN H | Mar 04, 1982 | Substantially Equivalent | American Dade |
| K792583 | GAMMA ARACHIS HYPOGEA LECTIN | Jan 16, 1980 | Substantially Equivalent | Gamma Biologicals, Inc. |
| K792582 | POLY-LEC SYSTEM | Jan 16, 1980 | Substantially Equivalent | Gamma Biologicals, Inc. |
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.