KSF — Kit, Quality Control For Blood Banking Reagents Class II
FDA product code KSF covers "Kit, Quality Control For Blood Banking Reagents", a Class II medical device regulated under 21 CFR 864.9650. Submissions are reviewed by the Hematology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSF
- Device Class
- Class II
- Regulation Number
- 864.9650
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K811713 | ortho diagnostic systems | AVI-D CONTROL | October 23, 1981 |
| K810599 | american dade | DADE RH CONTROL REAGENT | March 31, 1981 |
| K801425 | north american biologicals | RH CONTROL | July 14, 1980 |
| K800658 | gamma biologicals | RST-SERIES CONTROL | April 16, 1980 |
| K800310 | ortho diagnostics | ORTHO ANTISERA CONTROL | March 5, 1980 |
| K800239 | gotham biologics | RH-HR NEGATIVE CONTROL REAGENT | February 21, 1980 |
| K790249 | hyland therapeutic div., travenol laboratories | TEST CELLS | May 16, 1979 |
| K790025 | diagnostic technology | COUNTER CHECK, H001, H002, H003 | January 17, 1979 |
| K780665 | bca biological corp. of america | RECAP | June 6, 1978 |
| K780097 | bd becton dickinson vacutainer systems preanalytic | QUALITY CONTROL SYSTEM, SPECTRA | April 24, 1978 |
| K771814 | ortho diagnostics | REAGENT CONFIDENCE SERA | November 7, 1977 |
| K761284 | dade, baxter travenol diagnostics | UNIVAL CONTROL CELLS | January 25, 1977 |