510(k) K781638
- Device
- Rubindex*direct System
- Applicant
- ORTHO DIAGNOSTICS, INC.
- 510(k) number
- K781638
- Product code
- GOK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-20
- Date received
- 1978-09-21
- Regulation
- 866.3510
- Classification name
- Antisera, Hai (Including Hai Control), Rubella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- 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#
- 1181055
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GOK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832228 | RUBASCAN LATEX CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-29 |
| K810835 | RUBAZYME - M | Abbott Laboratories | 1981-05-05 |
| K792635 | ANTIBODY TO RUBELLA VIRUS | Electro-Nucleonics Laboratories, Inc. | 1980-03-19 |
| K792133 | RUBELISA TEST KIT | Microbiological Assoc. | 1980-01-11 |
| K790122 | RUBANON | Organon, Inc. | 1979-02-15 |
| K781392 | CYTOMEGILISH TEST KIT | Microbiological Assoc. | 1978-10-24 |
| K780010 | GOAT ANTI-RUBELLA ANTISERA | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| K780063 | RUBENOSTICON | Organon, Inc. | 1978-01-20 |
| K771956 | HUMAN O BUFFER | Flow Laboratories, Inc. | 1977-10-28 |
| K771957 | RUBELLA HEMAGGLUTINATION REAGENT KIT | Flow Laboratories, Inc. | 1977-10-28 |