Rapid NFT, Modification
FDA 510(k) K922768 · Biomerieux Vitek, Inc.
510(k) numberK922768
Submission
- Device name
- Rapid NFT, Modification
- Applicant
- Biomerieux Vitek, Inc.
Hazelwood, MO, US - Received
- June 8, 1992
- Decision date
- October 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JSW – Kit, Identification, Glucose Nonfermenter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900517 | Rapid NF SystemJSW · Traditional | Innovative Diagnostic Systems, Inc. | 03/13/1990SE |
| K870769 | Austin Nonfermenter KitJSW · Traditional | Austin Biological Laboratories | 04/03/1987SE |
| K790992 | Pseudo-Palette TMJSW · Traditional | Micro-Palettes, Inc. | 06/22/1979SE |
| K772112 | Non-Fermenter SystemJSW · Traditional | Corning Medical & Scientific | 11/17/1977SE |
| K770745 | Panel, GNF, Micro-IdJSW · Traditional | Micro-Media Systems, Inc. | 06/23/1977SE |
More from Micro-Media Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973819 | Vidas D-Dimer (DD) AssayDAP · Traditional | 03/10/1998SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | 10/03/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | 05/05/1997SE |
| K964887 | Vidas C. Difficile Toxin a II AssayLLH · Traditional | 04/08/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | 10/07/1996SE |
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | 08/30/1996SE |
| K962549 | Vidas Creatine Kinase MB Assay 30-421JHX · Traditional | 08/30/1996SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | 03/12/1996SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | 02/06/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | 06/13/1995SE |
Questions and answers
When was Rapid NFT, Modification cleared by the FDA?
Rapid NFT, Modification (K922768) received a 510(k) decision of Substantially Equivalent on October 14, 1992, 128 days after the submission was received.
What is the product code of K922768?
The FDA product code is JSW – Kit, Identification, Glucose Nonfermenter, a Class I (low risk) device regulated under 21 CFR 866.2660.