Roche Oxi/Ferm II
FDA 510(k) K923313 · Roche Diagnostic Systems, Inc.
510(k) numberK923313
Submission
- Device name
- Roche Oxi/Ferm II
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- July 7, 1992
- Decision date
- April 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Roche Oxi/Ferm II cleared by the FDA?
Roche Oxi/Ferm II (K923313) received a 510(k) decision of Substantially Equivalent on April 5, 1993, 272 days after the submission was received.
What is the product code of K923313?
The FDA product code is LQM – Gram Negative Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.