Measles Virus Rubeola
FDA 510(k) K843662 · Institute Virion , Ltd.
510(k) numberK843662
Submission
- Device name
- Measles Virus Rubeola
- Applicant
- Institute Virion , Ltd.
Mchenry, IL, US - Received
- September 17, 1984
- Decision date
- September 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GRJ – Antigen, Cf, (Including Cf Control), Rubeola
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Specialty
- Microbiology
Other 510(k)s with product code GRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802932 | Measles Virus & ControlsGRJ · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
More from Orion Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862814 | Complement-Fixation Test for Campylobacter JejuniLQP · Traditional | 09/30/1986SE |
| K843676 | Varicella/Zoster VirusGQW · Traditional | 09/26/1985SE |
| K843673 | Respiratory Syncytial VirusGQG · Traditional | 09/26/1985SE |
| K843667 | Parainfluenza 3GQS · Traditional | 09/26/1985SE |
| K843665 | Parainfluenza 1GQS · Traditional | 09/26/1985SE |
| K843660 | In Fluenza B VirusGNX · Traditional | 09/26/1985SE |
| K843659 | Influenza A2 VirusGNX · Traditional | 09/26/1985SE |
| K843658 | H. Simplex VirusGQN · Traditional | 09/26/1985SE |
| K843657 | CytomegalovirusGQH · Traditional | 09/26/1985SE |
| K843649 | AdenovirusGOD · Traditional | 09/26/1985SE |
Questions and answers
When was Measles Virus Rubeola cleared by the FDA?
Measles Virus Rubeola (K843662) received a 510(k) decision of Substantially Equivalent on September 26, 1985, 374 days after the submission was received.
What is the product code of K843662?
The FDA product code is GRJ – Antigen, Cf, (Including Cf Control), Rubeola, a Class I (low risk) device regulated under 21 CFR 866.3520.