Vitek Rapid Call-Gram Negativ Ident Card
FDA 510(k) K925915 · Biomerieux Vitek, Inc.
510(k) numberK925915
Submission
- Device name
- Vitek Rapid Call-Gram Negativ Ident Card
- Applicant
- Biomerieux Vitek, Inc.
Hazelwood, MO, US - Received
- November 23, 1992
- Decision date
- March 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K912897 | Sceptor Identification SystemLQM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/28/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | Vitek Systems, Inc. | 06/24/1991SE |
| 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 |
|---|---|---|
| K973819 | Vidas D-Dimer (DD) AssayDAP · Traditional | 03/10/1998SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | 10/03/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | 05/05/1997SE |
| K964887 | Vidas C. Difficile Toxin a II AssayLLH · Traditional | 04/08/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | 10/07/1996SE |
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | 08/30/1996SE |
| K962549 | Vidas Creatine Kinase MB Assay 30-421JHX · Traditional | 08/30/1996SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | 03/12/1996SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | 02/06/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | 06/13/1995SE |
Questions and answers
When was Vitek Rapid Call-Gram Negativ Ident Card cleared by the FDA?
Vitek Rapid Call-Gram Negativ Ident Card (K925915) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 120 days after the submission was received.
What is the product code of K925915?
The FDA product code is LQM – Gram Negative Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.