Supplies, Blood-Bank
This device encompasses general blood bank supplies, including the variety of consumable items and materials used in blood bank operations such as specimen containers, labeling materials, and ancillary supplies that support blood collection, processing, testing, and storage activities. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KSS, regulated under 21 CFR 864.9050 within the Hematology specialty. No special flags apply.
Basic Information
- Product Code
- KSS
- Device Class
- FDA class 1
- Regulation Number
- 864.9050
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874436 | FLUID SAMPLING PACK | Jan 05, 1988 | Substantially Equivalent | U.S. MFG. & MANAGEMENT, INC. |
| K812892 | S/P SERUM DROPPER PIPETS | Oct 27, 1981 | Substantially Equivalent | AMERICAN DADE |
| K801516 | PRE-DENT SYSTEM MODIFIED | Jul 14, 1980 | Substantially Equivalent | PRE-DENT SYSTEM |
| K801386 | PRE-DENT SYSTEM OR PRE-DENT II | Jul 14, 1980 | Substantially Equivalent | PRE-DENT SYSTEM |
| K800736 | PRE-DENT SYSTEM | Apr 24, 1980 | Substantially Equivalent | PRE-DENT SYSTEM |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dec 30, 1976 | Substantially Equivalent | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.