Imagen
FDA 510(k) K943557 · Dako Diagnostics , Ltd.
510(k) numberK943557
Submission
- Device name
- Imagen
- Applicant
- Dako Diagnostics , Ltd.
Cambridgeshire, GB - Received
- July 22, 1994
- Decision date
- January 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
|---|---|---|
| K981226 | Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test…GQP · Traditional | 09/28/1998SE |
| K973954 | Imagen Respiratory ScreenGNW · Traditional | 12/22/1997SE |
| K962037 | Imagen Respiratory ScreenGNW · Traditional | 12/26/1996SE |
| K940564 | Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional | 01/11/1996SE |
| K932384 | Ideia(Tm) RotavirusLIQ · Traditional | 12/27/1993SE |
Questions and answers
When was Imagen cleared by the FDA?
Imagen (K943557) received a 510(k) decision of Substantially Equivalent on January 9, 1995, 171 days after the submission was received.
What is the product code of K943557?
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.