D3 Duet Dfa Rsv/Respiratory Virus Screening Kit
FDA 510(k) K081928 · Diagnostic Hybrids, Inc.
510(k) numberK081928
Submission
- Device name
- D3 Duet Dfa Rsv/Respiratory Virus Screening Kit
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- July 7, 2008
- Decision date
- December 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code LKT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983336 | Pathodx Respiratory Virus Panel Model PKRP1LKT · Traditional | Diagnostic Products Corp. | 03/18/1999SE |
| K943317 | Pathodx Respiratory Syncytial Virus (RSV)LKT · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K942173 | RSV Antigen TestLKT · Traditional | Neogenex | 06/30/1994SE |
| K912842 | Rsv-Mab TestLKT · Traditional | Gull Laboratories, Inc. | 12/09/1991SE |
| K912838 | Bartels Respiratory Syncytial Virus Enzyme ImmunoLKT · Traditional | Baxter Diagnostics, Inc. | 09/27/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | Vitek Systems, Inc. | 09/23/1991SE |
| K894623 | Respiratory Syncytial VirusLKT · Traditional | Bion Ent., Ltd. | 10/16/1989SE |
| K884192 | RSV Ifa Test Kit for Direct Antigen DetectionLKT · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K882687 | Anti-Respiratory Syncytial Virus Antibody TestLKT · Traditional | Gull Laboratories, Inc. | 08/30/1988SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | Genetic Systems Corp. | 11/20/1987SE |
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Questions and answers
When was D3 Duet Dfa Rsv/Respiratory Virus Screening Kit cleared by the FDA?
D3 Duet Dfa Rsv/Respiratory Virus Screening Kit (K081928) received a 510(k) decision of Substantially Equivalent on December 23, 2008, 169 days after the submission was received.
What is the product code of K081928?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.