KSS — Supplies, Blood-Bank Class I
FDA product code KSS covers "Supplies, Blood-Bank", a Class I medical device regulated under 21 CFR 864.9050. Submissions are reviewed by the Hematology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSS
- Device Class
- Class I
- Regulation Number
- 864.9050
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K874436 | u.s. mfg. and management | FLUID SAMPLING PACK | January 5, 1988 |
| K812892 | american dade | S/P SERUM DROPPER PIPETS | October 27, 1981 |
| K801516 | pre-dent system | PRE-DENT SYSTEM MODIFIED | July 14, 1980 |
| K801386 | pre-dent system | PRE-DENT SYSTEM OR PRE-DENT II | July 14, 1980 |
| K800736 | pre-dent system | PRE-DENT SYSTEM | April 24, 1980 |
| K761303 | dade, baxter travenol diagnostics | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | December 30, 1976 |