KSF — Kit, Quality Control For Blood Banking Reagents Class II
FDA Device Classification
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 |