Ids Porphyrin Reagent
FDA 510(k) K812859 · Innovative Diagnostic Systems, Inc.
510(k) numberK812859
Submission
- Device name
- Ids Porphyrin Reagent
- Applicant
- Innovative Diagnostic Systems, Inc.
Atlanta, GA, US - Received
- October 13, 1981
- Decision date
- October 26, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050352 | In-Vitro Diagnostic Vaginitis Test KitJTO · Traditional | Ameritek Research, LLC | 09/01/2005SE |
| K970832 | Pyr SwabJTO · Traditional | Remel, Inc. | 04/24/1997SE |
| K970834 | Gram SwabJTO · Traditional | Remel, Inc. | 04/17/1997SE |
| K970833 | Indole SwabJTO · Traditional | Remel, Inc. | 04/02/1997SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | Microbiologics, Inc. | 02/06/1997SE |
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
| K961191 | ColiscreenJTO · Traditional | Hardy Diagnostics | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
More from Difco Laboratories, Inc.
| 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 |
| K820483 | Ida Rapid O2A SystemJSP · Traditional | 03/15/1982SE |
Questions and answers
When was Ids Porphyrin Reagent cleared by the FDA?
Ids Porphyrin Reagent (K812859) received a 510(k) decision of Substantially Equivalent on October 26, 1981, 13 days after the submission was received.
What is the product code of K812859?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.