510(k) K771814
- Device
- Reagent Confidence Sera
- Applicant
- ORTHO DIAGNOSTICS, INC.
- 510(k) number
- K771814
- Product code
- KSF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-07
- Date received
- 1977-09-27
- Regulation
- 864.9650
- Classification name
- Kit, Quality Control For Blood Banking Reagents
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006261638
- 9610824
- 1000124057
- 3007088335
- 9610805
- 3012963943
- 2250051
- 1177732
- 3004910133
- 3011683976
- 1061932
- 2016706
- 1017835
- 1034569
- 3016014873
- 3002642396
- 3002806769
- 1319681
- 3000308930
- 1056600
- 3010127294
- 3017237798
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K761284 | UNIVAL CONTROL CELLS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 |