510(k) K843662
- Device
- MEASLES VIRUS RUBEOLA
- Applicant
- INSTITUTE VIRION LTD.
- 510(k) number
- K843662
- Product code
- GRJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-26
- Date received
- 1984-09-17
- Regulation
- 866.3520
- Classification name
- Antigen, Cf, (including Cf Control), Rubeola
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K802932 | MEASLES VIRUS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 |
Legacy Summary#
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FDA Review#
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