Reagent Confidence Sera
FDA 510(k) K771814 · Ortho Diagnostics, Inc.
510(k) numberK771814
Submission
- Device name
- Reagent Confidence Sera
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- September 27, 1977
- Decision date
- November 7, 1977
- 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 |
| 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 |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
Questions and answers
When was Reagent Confidence Sera cleared by the FDA?
Reagent Confidence Sera (K771814) received a 510(k) decision of Substantially Equivalent on November 7, 1977, 41 days after the submission was received.
What is the product code of K771814?
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.