Alamar Bacterial Identification Test Panel
FDA 510(k) K926002 · Alamar Biosciences Laboratory, Inc.
510(k) numberK926002
Submission
- Device name
- Alamar Bacterial Identification Test Panel
- Applicant
- Alamar Biosciences Laboratory, Inc.
Sacramento, CA, US - Received
- November 27, 1992
- Decision date
- September 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JSS – Kit, Identification, Enterobacteriaceae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150031 | hemoFISH MasterpanelJSS · Traditional | Miacom Diagnostics GmbH | 10/01/2015SE |
| K123418 | Gram-Negative Quickfish BCJSS · Traditional | Advandx, Inc. | 07/21/2013SE |
| K101558 | GNR Traffic Light Pna FishJSS · Traditional | Advandx, Inc. | 12/16/2010SE |
| K092236 | E.Coli/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 12/16/2009SE |
| K092393 | Ek/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 09/01/2009SE |
| K082068 | E. Coli Pna FishJSS · Traditional | Advandx, Inc. | 06/25/2009SE |
| K081433 | Ek/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 03/26/2009SE |
| K081309 | E.Coli/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 12/19/2008SE |
| K926018 | Crystal Enteric/Nonfermenter Id SystemJSS · Traditional | Becton Dickinson Microbiology Systems | 03/11/1993SE |
| K926017 | Crystal Rapid Stool/Enteric Id SystemJSS · Traditional | Becton Dickinson Microbiology Systems | 03/11/1993SE |
More from Becton Dickinson Microbiology Systems
| 510(k) | Device | Decision |
|---|---|---|
| K941425 | Alamar Antibiotic SusceptibilityLRG · Traditional | 12/15/1994SE |
| K926248 | ReaderLRH · Traditional | 05/17/1994SE |
| K925951 | ReadarLRG · Traditional | 08/31/1993SE |
| K930469 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 06/25/1993SE |
| K930055 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 04/05/1993SE |
| K924500 | Antimicrobial Susceptibility TestJWY · Traditional | 11/30/1992SE |
| K922780 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 08/20/1992SE |
| K922003 | Antimicrobial Suscetibility Test PanelJWY · Traditional | 08/19/1992SE |
| K922168 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 07/28/1992SE |
| K911558 | Antimicrobial Suscept. Test Panel NitrofurantoinJWY · Traditional | 05/15/1991SE |
Questions and answers
When was Alamar Bacterial Identification Test Panel cleared by the FDA?
Alamar Bacterial Identification Test Panel (K926002) received a 510(k) decision of Substantially Equivalent on September 23, 1993, 300 days after the submission was received.
What is the product code of K926002?
The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.