Austin Nonfermenter Kit
FDA 510(k) K870769 · Austin Biological Laboratories
510(k) numberK870769
Submission
- Device name
- Austin Nonfermenter Kit
- Applicant
- Austin Biological Laboratories
Austin, TX, US - Received
- February 26, 1987
- Decision date
- April 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSW – Kit, Identification, Glucose Nonfermenter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922768 | Rapid NFT, ModificationJSW · Traditional | Biomerieux Vitek, Inc. | 10/14/1992SE |
| K900517 | Rapid NF SystemJSW · Traditional | Innovative Diagnostic Systems, Inc. | 03/13/1990SE |
| K790992 | Pseudo-Palette TMJSW · Traditional | Micro-Palettes, Inc. | 06/22/1979SE |
| K772112 | Non-Fermenter SystemJSW · Traditional | Corning Medical & Scientific | 11/17/1977SE |
| K770745 | Panel, GNF, Micro-IdJSW · Traditional | Micro-Media Systems, Inc. | 06/23/1977SE |
More from Micro-Media Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880511 | Xact NeisseriaJSX · Traditional | 08/25/1988SE |
| K874727 | Precept(Tm) CiprofloxacinJWY · Traditional | 02/18/1988SE |
| K864069 | Precept (TM) Ticarcillin/Clavulanic AcidJWY · Traditional | 11/13/1986SE |
| K862560 | Precept CeftizoximeJWY · Traditional | 07/11/1986SE |
| K862446 | Precept CeftazidimeJWY · Traditional | 07/11/1986SE |
| K860195 | Precept Trimethoprim/SulfamethoxazoleJWY · Traditional | 02/20/1986SE |
| K860194 | Austin Enteric SystemJSE · Traditional | 02/20/1986SE |
| K854577 | Precept Amoxicillin/Clavvlanic Acid (Augmentin)JWY · Traditional | 02/05/1986SE |
| K853772 | Precept MethicillinLTW · Traditional | 09/16/1985SE |
| K853685 | Precept TM CarbenicillinLTW · Traditional | 09/16/1985SE |
Questions and answers
When was Austin Nonfermenter Kit cleared by the FDA?
Austin Nonfermenter Kit (K870769) received a 510(k) decision of Substantially Equivalent on April 3, 1987, 36 days after the submission was received.
What is the product code of K870769?
The FDA product code is JSW – Kit, Identification, Glucose Nonfermenter, a Class I (low risk) device regulated under 21 CFR 866.2660.