Anaerobe Kit
FDA 510(k) K850052 · Austin Biological Laboratories
510(k) numberK850052
Submission
- Device name
- Anaerobe Kit
- Applicant
- Austin Biological Laboratories
Austin, TX, US - Received
- January 8, 1985
- Decision date
- March 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSP – Kit, Anaerobic Identification
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945489 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K945488 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K945487 | Lyfo(Tm) Differential DiskJSP · Traditional | Microbiologics, Inc. | 05/11/1995SE |
| K944528 | Bblcrystal Anaerobe Id SystemJSP · Traditional | Becton Dickinson Microbiology Systems | 03/07/1995SE |
| K910666 | Vitek Anaerobe Identification Card, ModificationJSP · Traditional | Vitek Systems, Inc. | 04/03/1991SE |
| K900996 | Vitek Anaerobe Identification CardJSP · Traditional | Vitek Systems, Inc. | 05/11/1990SE |
| K881380 | B. FragtexJSP · Traditional | American Biomedical Products, Inc. | 10/06/1988SE |
| K882960 | Ids Rapid Ana SystemJSP · Traditional | Innovative Diagnostic Systems, Inc. | 08/12/1988SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | Oxoid U.S.A., Inc. | 11/04/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | American Micro Scan | 08/27/1986SE |
More from American Micro Scan
| 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 Anaerobe Kit cleared by the FDA?
Anaerobe Kit (K850052) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 56 days after the submission was received.
What is the product code of K850052?
The FDA product code is JSP – Kit, Anaerobic Identification, a Class I (low risk) device regulated under 21 CFR 866.2660.