Crystal Enteric/Nonfermenter Id System
FDA 510(k) K926018 · Becton Dickinson Microbiology Systems
510(k) numberK926018
Submission
- Device name
- Crystal Enteric/Nonfermenter Id System
- Applicant
- Becton Dickinson Microbiology Systems
Cockeysville, MD, US - Received
- November 30, 1992
- Decision date
- March 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K926002 | Alamar Bacterial Identification Test PanelJSS · Traditional | Alamar Biosciences Laboratory, Inc. | 09/23/1993SE |
| K926017 | Crystal Rapid Stool/Enteric Id SystemJSS · Traditional | Becton Dickinson Microbiology Systems | 03/11/1993SE |
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Questions and answers
When was Crystal Enteric/Nonfermenter Id System cleared by the FDA?
Crystal Enteric/Nonfermenter Id System (K926018) received a 510(k) decision of Substantially Equivalent on March 11, 1993, 101 days after the submission was received.
What is the product code of K926018?
The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.