Vitek Gram Negative Identification Card, Modified
FDA 510(k) K911429 · Vitek Systems, Inc.
510(k) numberK911429
Submission
- Device name
- Vitek Gram Negative Identification Card, Modified
- Applicant
- Vitek Systems, Inc.
Hazelwood, MI, US - Received
- March 26, 1991
- Decision date
- June 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQM – Gram Negative Identification Panel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923313 | Roche Oxi/Ferm IILQM · Traditional | Roche Diagnostic Systems, Inc. | 04/05/1993SE |
| K925915 | Vitek Rapid Call-Gram Negativ Ident CardLQM · Traditional | Biomerieux Vitek, Inc. | 03/23/1993SE |
| K912897 | Sceptor Identification SystemLQM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/28/1991SE |
| K890057 | Sensititre Auto Id Plate AP80LQM · Traditional | Radiometer America, Inc. | 06/09/1989SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | American Micro Scan | 09/11/1986SE |
| K851528 | Pasco Gram Negative Identification SystemLQM · Traditional | Pasco Laboratories, Inc. | 07/15/1985SE |
More from Pasco Laboratories, Inc.
| 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 |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
Questions and answers
When was Vitek Gram Negative Identification Card, Modified cleared by the FDA?
Vitek Gram Negative Identification Card, Modified (K911429) received a 510(k) decision of Substantially Equivalent on June 24, 1991, 90 days after the submission was received.
What is the product code of K911429?
The FDA product code is LQM – Gram Negative Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.