Quadra-Titer (TM) I.D. (Modification)
FDA 510(k) K861774 · Microtech Medical Systems, Inc.
510(k) numberK861774
Submission
- Device name
- Quadra-Titer (TM) I.D. (Modification)
- Applicant
- Microtech Medical Systems, Inc.
Aurora, CO, US - Received
- May 7, 1986
- Decision date
- May 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K935485 | Fas Fastidious Mic PanelJWY · Traditional | 02/16/1995SE |
| K901598 | Fastidious Mic PanelJWY · Traditional | 11/08/1990SE |
| K896332 | Supplement to Anaerobic Mic PanelJWY · Traditional | 02/05/1990SE |
| K884831 | Anaerobic Mic PanelJWY · Traditional | 03/27/1989SE |
| K863847 | Mic - Concept(Tm) RX-2JWY · Traditional | 12/18/1986SE |
| K860208 | Quadra-Titer I.D.JSS · Traditional | 03/03/1986SE |
| K852613 | Mic-Concept SystemLTW · Traditional | 09/20/1985SE |
| K853745 | Mic-Concept ViewboxLIB · Traditional | 09/19/1985SE |
| K850725 | Quadra Titer Micro PlatesLIB · Traditional | 04/30/1985SE |
| K851020 | Mic-Concept InoculatorJTC · Traditional | 03/29/1985SE |
Questions and answers
When was Quadra-Titer (TM) I.D. (Modification) cleared by the FDA?
Quadra-Titer (TM) I.D. (Modification) (K861774) received a 510(k) decision of Substantially Equivalent on May 20, 1986, 13 days after the submission was received.
What is the product code of K861774?
The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.