P.I.V. Complement-Fixation (C.F.) Antigen
FDA 510(k) K905385 · Virion (U.S.), Inc.
510(k) numberK905385
Submission
- Device name
- P.I.V. Complement-Fixation (C.F.) Antigen
- Applicant
- Virion (U.S.), Inc.
Morristown, NJ, US - Received
- November 30, 1990
- Decision date
- March 21, 1991
- 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 |
| 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 |
| K843665 | Parainfluenza 1GQS · 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 |
|---|---|---|
| K933251 | Epstein-Barr Virus Combi Test, Ebv Combi TestMCD · Traditional | 06/13/1994SE |
| K921618 | Coxsackie Virus B1-B6 CF AntigensGNG · Traditional | 06/29/1992SE |
| K905306 | Mumps Complement-Fixation (C.F.) AntigenGRC · Traditional | 06/17/1991SE |
| K864981 | Toxoplasma GondiiGMN · Traditional | 10/30/1987SE |
Questions and answers
When was P.I.V. Complement-Fixation (C.F.) Antigen cleared by the FDA?
P.I.V. Complement-Fixation (C.F.) Antigen (K905385) received a 510(k) decision of Substantially Equivalent on March 21, 1991, 111 days after the submission was received.
What is the product code of K905385?
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.