Micro-Id
FDA 510(k) K760790 · General Diagnostics
510(k) numberK760790
Submission
- Device name
- Micro-Id
- Applicant
- General Diagnostics
Mchenry, IL, US - Received
- October 7, 1976
- Decision date
- October 29, 1976
- 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 |
|---|---|---|
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
| K872882 | Cannabinoid Enzyme Immunoassay KitLDJ · Traditional | 11/03/1987SE |
| K871305 | Cocaine Metabolite Enzyme Immunoassay KitDIO · Traditional | 06/05/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
Questions and answers
When was Micro-Id cleared by the FDA?
Micro-Id (K760790) received a 510(k) decision of Substantially Equivalent on October 29, 1976, 22 days after the submission was received.
What is the product code of K760790?
The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.