Genetic Systems RSV Immunofluorescence Test Kit
FDA 510(k) K870176 · Genetic Systems Corp.
510(k) numberK870176
Submission
- Device name
- Genetic Systems RSV Immunofluorescence Test Kit
- Applicant
- Genetic Systems Corp.
Seattle, WA, US - Received
- January 15, 1987
- Decision date
- July 16, 1987
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Gull Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K891767 | Genetic Systems Microplate ReaderJJQ · Traditional | 07/25/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | 05/01/1989SE |
| K890768 | Pneumocystis Carinii Immunofluorescence Test KitLYF · Traditional | 03/21/1989SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | 09/23/1987SE |
| K870879 | Alanine Transaminase (Alt) Test KitCKA · Traditional | 03/19/1987SE |
| K863566 | GSC 1000JJQ · Traditional | 10/16/1986SE |
| K852237 | Legionella Immunofluorescent Antibody Test KitLHL · Traditional | 08/22/1985SE |
Questions and answers
When was Genetic Systems RSV Immunofluorescence Test Kit cleared by the FDA?
Genetic Systems RSV Immunofluorescence Test Kit (K870176) received a 510(k) decision of Substantially Equivalent on July 16, 1987, 182 days after the submission was received.
What is the product code of K870176?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.