Api 20E/UNISCEPT 20E
FDA 510(k) K924814 · Analytical Products, Inc.
510(k) numberK924814
Submission
- Device name
- Api 20E/UNISCEPT 20E
- Applicant
- Analytical Products, Inc.
Plainview, NY, US - Received
- September 25, 1992
- Decision date
- March 11, 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 |
| K926002 | Alamar Bacterial Identification Test PanelJSS · Traditional | Alamar Biosciences Laboratory, Inc. | 09/23/1993SE |
| K926018 | Crystal Enteric/Nonfermenter Id SystemJSS · Traditional | Becton Dickinson Microbiology Systems | 03/11/1993SE |
More from Becton Dickinson Microbiology Systems
| 510(k) | Device | Decision |
|---|---|---|
| K923684 | Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional | 12/03/1992SE |
| K922926 | Api Uniscept Kb/Type 2 and 3JWY · Traditional | 10/13/1992SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | 09/10/1990SE |
| K901390 | Dmac Indole ReagentJTO · Traditional | 04/16/1990SE |
| K895796 | Api Uniscept KBJWY · Traditional | 11/13/1989SE |
| K884510 | Modification Micro-MicJWY · Traditional | 11/22/1988SE |
| K884509 | Modification Mic/Api Uniscept(R)JWY · Traditional | 11/22/1988SE |
| K880598 | Modifications to Api Uniscept (R) KBJWY · Traditional | 03/23/1988SE |
| K874466 | Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional | 12/09/1987SE |
| K865062 | Aladin (TM)LRG · Traditional | 03/25/1987SE |
Questions and answers
When was Api 20E/UNISCEPT 20E cleared by the FDA?
Api 20E/UNISCEPT 20E (K924814) received a 510(k) decision of Substantially Equivalent on March 11, 1993, 167 days after the submission was received.
What is the product code of K924814?
The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.