Slidex Meningite-Kit 5
FDA 510(k) K910210 · Vitek Systems, Inc.
510(k) numberK910210
Submission
- Device name
- Slidex Meningite-Kit 5
- Applicant
- Vitek Systems, Inc.
Hazelwood, MI, US - Received
- January 15, 1991
- Decision date
- August 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTJ – Antisera, All Groups, N. Meningitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code GTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952791 | Directigen Meningitis Combo TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/30/1996SE |
| K915330 | Directigen Meningitis Combo Test KitGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/23/1992SE |
| K885004 | Bactigen(R) N. MeningitidisGTJ · Traditional | Armkel, LLC | 02/07/1989SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | Microscan Div. Baxter Healthcare Corp. | 03/17/1987SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K844999 | Phadebact CSF TestGTJ · Traditional | Pharmacia, Inc. | 10/17/1985SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | Wellcome Diagnostics | 06/10/1985SE |
| K844762 | Meningococcus Group B Monoclonal Antibody ZM-51GTJ · Traditional | Wellcome Diagnostics | 06/04/1985SE |
| K844407 | Directigen Neissena Menningitidis Group B TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/25/1985SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| 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 |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| 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 Slidex Meningite-Kit 5 cleared by the FDA?
Slidex Meningite-Kit 5 (K910210) received a 510(k) decision of Substantially Equivalent on August 12, 1991, 209 days after the submission was received.
What is the product code of K910210?
The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.