Rapid Gram-Positive Id System
FDA 510(k) K961730 · Becton Dickinson Microbiology Systems
510(k) numberK961730
Submission
- Device name
- Rapid Gram-Positive Id System
- Applicant
- Becton Dickinson Microbiology Systems
Cockeysville, MD, US - Received
- May 3, 1996
- Decision date
- February 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | American Micro Scan | 09/30/1986SE |
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Questions and answers
When was Rapid Gram-Positive Id System cleared by the FDA?
Rapid Gram-Positive Id System (K961730) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 277 days after the submission was received.
What is the product code of K961730?
The FDA product code is LQL – Gram Positive Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.