Precept Netilmicin 32-13
FDA 510(k) K853687 · Austin Biological Laboratories
510(k) numberK853687
Submission
- Device name
- Precept Netilmicin 32-13
- Applicant
- Austin Biological Laboratories
Austin, TX, US - Received
- March 1, 1985
- Decision date
- September 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LTW – Susceptibility Test Cards, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852613 | Mic-Concept SystemLTW · Traditional | Microtech Medical Systems, Inc. | 09/20/1985SE |
| K853772 | Precept MethicillinLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853685 | Precept TM CarbenicillinLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853596 | Precept CefoperazoneLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853273 | Precept CeftriaxoneLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853689 | Precept TM MoxalactamLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853688 | Precept TM TobramycinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853686 | Precept TM AmikacinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853684 | Precept KanamycinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853263 | Precept AvgmentinLTW · Traditional | Austin Biological Laboratories | 08/29/1985SE |
More from Austin Biological Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K880511 | Xact NeisseriaJSX · Traditional | 08/25/1988SE |
| K874727 | Precept(Tm) CiprofloxacinJWY · Traditional | 02/18/1988SE |
| K870769 | Austin Nonfermenter KitJSW · Traditional | 04/03/1987SE |
| 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 |
Questions and answers
When was Precept Netilmicin 32-13 cleared by the FDA?
Precept Netilmicin 32-13 (K853687) received a 510(k) decision of Substantially Equivalent on September 13, 1985, 196 days after the submission was received.
What is the product code of K853687?
The FDA product code is LTW – Susceptibility Test Cards, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.