Rst-Series Control
FDA 510(k) K800658 · Gamma Biologicals, Inc.
510(k) numberK800658
Submission
- Device name
- Rst-Series Control
- Applicant
- Gamma Biologicals, Inc.
Mchenry, IL, US - Received
- March 26, 1980
- Decision date
- April 16, 1980
- 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 |
| K800310 | Ortho Antisera ControlKSF · Traditional | Ortho Diagnostics, Inc. | 03/05/1980SE |
| K800239 | Rh-Hr Negative Control ReagentKSF · Traditional | Gotham Biologics, Inc. | 02/21/1980SE |
| K790249 | Test CellsKSF · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 05/16/1979SE |
| 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 |
|---|---|---|
| K864207 | Disposable Test Cards/Gamma Slide Test Infect MonoKTN · Traditional | 12/03/1986SE |
| K861016 | Gamma Slide Test for Infectious MononucleosisKTN · Traditional | 04/18/1986SE |
| K832473 | Gamma Slide Test for PregnancyJHJ · Traditional | 08/16/1983SE |
| K820647 | Gamma Fetal Bleed Screening TestLIM · Traditional | 05/12/1982SE |
| K820072 | Fe-Cult PlusKHE · Traditional | 03/04/1982SE |
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | 03/04/1982SE |
| K811752 | Fe-Cult PlusKHE · Traditional | 11/02/1981SE |
| K802534 | Gamma Pi Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K792583 | Gamma Arachis Hypogea LectinKSI · Traditional | 01/16/1980SE |
Questions and answers
When was Rst-Series Control cleared by the FDA?
Rst-Series Control (K800658) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 21 days after the submission was received.
What is the product code of K800658?
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.