RH Control
FDA 510(k) K801425 · North American Biologicals, Inc.
510(k) numberK801425
Submission
- Device name
- RH Control
- Applicant
- North American Biologicals, Inc.
Mchenry, IL, US - Received
- June 17, 1980
- Decision date
- July 14, 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 |
| 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 |
| 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 |
|---|---|---|
| K820301 | Plasma Pooler Heat SealerKSD · Traditional | 04/09/1982SE |
| K801219 | PlasmapoolerKSR · Traditional | 10/31/1980SE |
| K781896 | Blood Group Substance A,BKSX · Traditional | 12/20/1978SE |
| K781895 | Blood Group Substance BKSX · Traditional | 12/20/1978SE |
| K781862 | Blood Group Substance aKSX · Traditional | 12/20/1978SE |
Questions and answers
When was RH Control cleared by the FDA?
RH Control (K801425) received a 510(k) decision of Substantially Equivalent on July 14, 1980, 27 days after the submission was received.
What is the product code of K801425?
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.