Monabrite Respir Syncytial Virus(Rsv) Test Kit
FDA 510(k) K861379 · Serono Diagnostics, Inc.
510(k) numberK861379
Submission
- Device name
- Monabrite Respir Syncytial Virus(Rsv) Test Kit
- Applicant
- Serono Diagnostics, Inc.
Norwell, MA, US - Received
- April 14, 1986
- Decision date
- July 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | Diagnostic Hybrids, Inc. | 12/23/2008SE |
| 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 |
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|---|---|---|
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| K883085 | T3 Uptake Serozyme Enzyme Immuno Kt/Mag Solid PhasKHQ · Traditional | 09/09/1988SE |
| K882340 | LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaCEP · Traditional | 08/08/1988SE |
| K880388 | T3 Serozyme Enzymeimmunoassay Kit, Mag Solid PhaseCDP · Traditional | 03/03/1988SE |
| K874866 | T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid PhaseKLI · Traditional | 02/11/1988SE |
| K873431 | Progesterone Maia Radioimmuno Assay Kit Mag SLD PHJLS · Traditional | 10/20/1987SE |
| K873186 | LH Maiaclone Immunoradio. Assay Kit, Mag Solid PhaCEP · Traditional | 09/29/1987SE |
| K873400 | Prolactin Maiaclone Immunoradio. Kit, Mag Sol PhaCFT · Traditional | 09/25/1987SE |
| K872862 | PRL Serozyme Immunoenz. Assay Kit, Mag. Solid PhasCFT · Traditional | 09/18/1987SE |
Questions and answers
When was Monabrite Respir Syncytial Virus(Rsv) Test Kit cleared by the FDA?
Monabrite Respir Syncytial Virus(Rsv) Test Kit (K861379) received a 510(k) decision of Substantially Equivalent on July 16, 1986, 93 days after the submission was received.
What is the product code of K861379?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.