Gram Negative Fluorescent Identification Panel
FDA 510(k) K862642 · American Micro Scan
510(k) numberK862642
Submission
- Device name
- Gram Negative Fluorescent Identification Panel
- Applicant
- American Micro Scan
West Sacramento, CA, US - Received
- July 11, 1986
- Decision date
- September 11, 1986
- 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 |
| 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 |
| K851528 | Pasco Gram Negative Identification SystemLQM · Traditional | Pasco Laboratories, Inc. | 07/15/1985SE |
More from Pasco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | 03/25/1987SE |
| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | 08/27/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
| K861584 | Gram Negative Combo Panel Type 3JWY · Traditional | 06/17/1986SE |
| K860575 | Yeast Identification PanelJXB · Traditional | 05/13/1986SE |
Questions and answers
When was Gram Negative Fluorescent Identification Panel cleared by the FDA?
Gram Negative Fluorescent Identification Panel (K862642) received a 510(k) decision of Substantially Equivalent on September 11, 1986, 62 days after the submission was received.
What is the product code of K862642?
The FDA product code is LQM – Gram Negative Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.