Biomerieux RSV Direct If Kit
FDA 510(k) K912371 · Vitek Systems, Inc.
510(k) numberK912371
Submission
- Device name
- Biomerieux RSV Direct If Kit
- Applicant
- Vitek Systems, Inc.
Hazelwood, MI, US - Received
- May 29, 1991
- Decision date
- September 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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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 |
| 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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|---|---|---|
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| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | 06/24/1991SE |
Questions and answers
When was Biomerieux RSV Direct If Kit cleared by the FDA?
Biomerieux RSV Direct If Kit (K912371) received a 510(k) decision of Substantially Equivalent on September 23, 1991, 117 days after the submission was received.
What is the product code of K912371?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.