Quality Control System, Spectra
FDA 510(k) K780097 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK780097
Submission
- Device name
- Quality Control System, Spectra
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- January 19, 1978
- Decision date
- April 24, 1978
- 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 |
| K771814 | Reagent Confidence SeraKSF · Traditional | Ortho Diagnostics, Inc. | 11/07/1977SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Quality Control System, Spectra cleared by the FDA?
Quality Control System, Spectra (K780097) received a 510(k) decision of Substantially Equivalent on April 24, 1978, 95 days after the submission was received.
What is the product code of K780097?
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.