Parainfluenza 1
FDA 510(k) K843665 · Institute Virion , Ltd.
510(k) numberK843665
Submission
- Device name
- Parainfluenza 1
- 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
- GQS – Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3400
- Specialty
- Microbiology
Other 510(k)s with product code GQS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitGQS · Traditional | Diagnostic Hybrids, Inc. | 12/23/2009SE |
| K943557 | ImagenGQS · Traditional | Dako Diagnostics , Ltd. | 01/09/1995SE |
| K905385 | P.I.V. Complement-Fixation (C.F.) AntigenGQS · Traditional | Virion (U.S.), Inc. | 03/21/1991SE |
| K884194 | Parainfluenza Type 1 Ifa Test Kit for Anti. DetectGQS · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K884193 | Parainfluenza Type 3 Ifa Test Kit for Anti. DetectGQS · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K871234 | Antibody Assay for Detect. of Parainfluenza Type 1GQS · Traditional | Microscan Div. Baxter Healthcare Corp. | 06/26/1987SE |
| K871232 | Antibody Assay for Detect. of Parainfluenza Type 3GQS · Traditional | Microscan Div. Baxter Healthcare Corp. | 06/26/1987SE |
| K871228 | Antibody Assay for Detect. of Parainfluenza Type 2GQS · Traditional | Microscan Div. Baxter Healthcare Corp. | 06/26/1987SE |
| K843667 | Parainfluenza 3GQS · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K802935 | Parainfluenza 1,2, & 3 Antigens & ContrGQS · 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 |
| K843662 | Measles Virus RubeolaGRJ · 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 Parainfluenza 1 cleared by the FDA?
Parainfluenza 1 (K843665) 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 K843665?
The FDA product code is GQS – Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, a Class I (low risk) device regulated under 21 CFR 866.3400.