Anaerobe Rapid Chromogenic Id Panel
FDA 510(k) K862332 · American Micro Scan
510(k) numberK862332
Submission
- Device name
- Anaerobe Rapid Chromogenic Id Panel
- Applicant
- American Micro Scan
West Sacramento, CA, US - Received
- June 19, 1986
- Decision date
- August 27, 1986
- 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 |
| K850052 | Anaerobe KitJSP · Traditional | Austin Biological Laboratories | 03/05/1985SE |
More from Austin Biological Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | 03/25/1987SE |
| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
| K861584 | Gram Negative Combo Panel Type 3JWY · Traditional | 06/17/1986SE |
| K860575 | Yeast Identification PanelJXB · Traditional | 05/13/1986SE |
Questions and answers
When was Anaerobe Rapid Chromogenic Id Panel cleared by the FDA?
Anaerobe Rapid Chromogenic Id Panel (K862332) received a 510(k) decision of Substantially Equivalent on August 27, 1986, 69 days after the submission was received.
What is the product code of K862332?
The FDA product code is JSP – Kit, Anaerobic Identification, a Class I (low risk) device regulated under 21 CFR 866.2660.