Ams Gram-Positive Ident. Card
FDA 510(k) K834389 · Vitek Systems, Inc.
510(k) numberK834389
Submission
- Device name
- Ams Gram-Positive Ident. Card
- Applicant
- Vitek Systems, Inc.
Mchenry, IL, US - Received
- December 14, 1983
- Decision date
- March 9, 1984
- 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
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
Questions and answers
When was Ams Gram-Positive Ident. Card cleared by the FDA?
Ams Gram-Positive Ident. Card (K834389) received a 510(k) decision of Substantially Equivalent on March 9, 1984, 86 days after the submission was received.
What is the product code of K834389?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.