Test Cells
FDA 510(k) K790249 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK790249
Submission
- Device name
- Test Cells
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- February 8, 1979
- Decision date
- May 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSF – Kit, Quality Control For Blood Banking Reagents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9650
- Specialty
- Hematology
Other 510(k)s with product code KSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K811713 | Avi-D ControlKSF · Traditional | Ortho Diagnostic Systems, Inc. | 10/23/1981SE |
| K810599 | Dade RH Control ReagentKSF · Traditional | American Dade | 03/31/1981SE |
| K801425 | RH ControlKSF · Traditional | North American Biologicals, Inc. | 07/14/1980SE |
| K800658 | Rst-Series ControlKSF · Traditional | Gamma Biologicals, Inc. | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | Ortho Diagnostics, Inc. | 03/05/1980SE |
| K800239 | Rh-Hr Negative Control ReagentKSF · Traditional | Gotham Biologics, Inc. | 02/21/1980SE |
| K790025 | Counter Check, H001, H002, H003KSF · Traditional | Diagnostic Technology, Inc. | 01/17/1979SE |
| K780665 | RecapKSF · Traditional | Bca Biological Corp. of America | 06/06/1978SE |
| K780097 | Quality Control System, SpectraKSF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/24/1978SE |
| K771814 | Reagent Confidence SeraKSF · Traditional | Ortho Diagnostics, Inc. | 11/07/1977SE |
More from Ortho Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820835 | Alumina Silica-Activated Partial ThromGFO · Traditional | 04/26/1982SE |
| K820192 | Haemophilus Influenzae Type B AntiserumGRP · Traditional | 03/11/1982SE |
| K812220 | Nephelometric Solid Turbidity StandardJIW · Traditional | 08/18/1981SE |
| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
| K780785 | Dilutor TransporterJQW · Traditional | 06/14/1978SE |
Questions and answers
When was Test Cells cleared by the FDA?
Test Cells (K790249) received a 510(k) decision of Substantially Equivalent on May 16, 1979, 97 days after the submission was received.
What is the product code of K790249?
The FDA product code is KSF – Kit, Quality Control For Blood Banking Reagents, a Class II (moderate risk) device regulated under 21 CFR 864.9650.