Ida Rapid O2A System
FDA 510(k) K820483 · Innovative Diagnostic Systems, Inc.
510(k) numberK820483
Submission
- Device name
- Ida Rapid O2A System
- Applicant
- Innovative Diagnostic Systems, Inc.
Atlanta, GA, US - Received
- February 22, 1982
- Decision date
- March 15, 1982
- 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 |
|---|---|---|
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | 10/08/1996SE |
| K943621 | Rapid Yeast Plus SystemJXB · Traditional | 01/27/1995SE |
| K900517 | Rapid NF SystemJSW · Traditional | 03/13/1990SE |
| K882960 | Ids Rapid Ana SystemJSP · Traditional | 08/12/1988SE |
| K881501 | Modified Ids Rapid NH SystemJSX · Traditional | 05/18/1988SE |
| K852871 | Ids Rapid Ss/U SystemJSS · Traditional | 07/23/1985SE |
| K852110 | Ids Rapid E Plus SystemJSS · Traditional | 06/04/1985SE |
| K833654 | Ids Rapid STR SystemJTO · Traditional | 02/13/1984SE |
| K822144 | Ids Staphylochrome TestJWX · Traditional | 08/24/1982SE |
| K812859 | Ids Porphyrin ReagentJTO · Traditional | 10/26/1981SE |
Questions and answers
When was Ida Rapid O2A System cleared by the FDA?
Ida Rapid O2A System (K820483) received a 510(k) decision of Substantially Equivalent on March 15, 1982, 21 days after the submission was received.
What is the product code of K820483?
The FDA product code is JSP – Kit, Anaerobic Identification, a Class I (low risk) device regulated under 21 CFR 866.2660.