Gram Positive Fluorescent Identification Panel
FDA 510(k) K863038 · American Micro Scan
510(k) numberK863038
Submission
- Device name
- Gram Positive Fluorescent Identification Panel
- Applicant
- American Micro Scan
West Sacramento, CA, US - Received
- August 12, 1986
- Decision date
- September 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQL – Gram Positive Identification Panel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | Accumed Intl., Inc. | 01/22/1998SE |
| K961968 | Bblcrystal Gram-Positive Id SystemLQL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1997SE |
| K961730 | Rapid Gram-Positive Id SystemLQL · Traditional | Becton Dickinson Microbiology Systems | 02/04/1997SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | Biomerieux Vitek, Inc. | 03/12/1996SE |
| K925916 | Vitek Rapid Call-Gram Positive Identification CardLQL · Traditional | Biomerieux Vitek, Inc. | 03/23/1993SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | Vitek Systems, Inc. | 07/26/1991SE |
| K910537 | Visi-StrepLQL · Traditional | Kev Connecticut Diagnostics, Inc. | 04/12/1991SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | Analytical Products, Inc. | 09/10/1990SE |
| K891004 | Rapidec StaphLQL · Traditional | Dms Products, Inc. | 11/09/1989SE |
| K874606 | Cathra Gram Positive ScreenLQL · Traditional | Mct Medical, Inc. | 05/06/1988SE |
More from Mct Medical, 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 |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| 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 Positive Fluorescent Identification Panel cleared by the FDA?
Gram Positive Fluorescent Identification Panel (K863038) received a 510(k) decision of Substantially Equivalent on September 30, 1986, 49 days after the submission was received.
What is the product code of K863038?
The FDA product code is LQL – Gram Positive Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.