510(k) BK140161
- Device
- Quality Control Kits For Blood Banking Reagents
- Applicant
- Hemo Bioscience
- 510(k) number
- BK140161
- Product code
- KSF
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2014-09-08
- Date received
- 2014-07-30
- Regulation
- 864.9650
- Classification name
- Kit, Quality Control For Blood Banking Reagents
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811713 | AVI-D CONTROL | Ortho Diagnostic Systems, Inc. | 1981-10-23 |
| K810599 | DADE RH CONTROL REAGENT | American Dade | 1981-03-31 |
| K801425 | RH CONTROL | North American Biologicals, Inc. | 1980-07-14 |
| K800658 | RST-SERIES CONTROL | Gamma Biologicals, Inc. | 1980-04-16 |
| K800310 | ORTHO ANTISERA CONTROL | Ortho Diagnostics, Inc. | 1980-03-05 |
| K800239 | RH-HR NEGATIVE CONTROL REAGENT | Gotham Biologics, Inc. | 1980-02-21 |
| K790249 | TEST CELLS | Hyland Therapeutic Div., Travenol Laboratories | 1979-05-16 |
| K790025 | COUNTER CHECK, H001, H002, H003 | Diagnostic Technology, Inc. | 1979-01-17 |
| K780665 | RECAP | Bca Biological Corp. of America | 1978-06-06 |
| K780097 | QUALITY CONTROL SYSTEM, SPECTRA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
| K771814 | REAGENT CONFIDENCE SERA | Ortho Diagnostics, Inc. | 1977-11-07 |
| K761284 | UNIVAL CONTROL CELLS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 |
Legacy Summary#
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FDA Review#
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