Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Multi-species erythrocyte suspensions used as serological reagents and equipment are preparations of red blood cells from various animal or human sources, used in hemagglutination and related serological tests to detect and characterize antibodies in patient specimens as part of microbiological or immunological testing. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LHW and is regulated under 21 CFR 866.3720 within the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LHW
- Device Class
- FDA class 1
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Review Panel
- MI
- 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 |
|---|---|---|---|---|
| K820849 | BLUE RIDGE RABBIT BLOOD | Apr 16, 1982 | Substantially Equivalent | Blue Ridge Media Co. |
| K820848 | BLUE RIDGE SHEEP BLOOD | Apr 16, 1982 | Substantially Equivalent | Blue Ridge Media Co. |
| K813513 | AFRICAN GREEN MONKEY BLOOD IN ALSERVERS | Dec 31, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K813512 | RHESUS MONKEY BLOOD IN ALSEVER'S | Dec 29, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |