Premier C. Difficile, Modification
FDA 510(k) K926442 · Meridian Diagnostics, Inc.
510(k) numberK926442
Submission
- Device name
- Premier C. Difficile, Modification
- Applicant
- Meridian Diagnostics, Inc.
Cincinnati, OH, US - Received
- December 16, 1992
- Decision date
- January 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LLH – Reagents, Clostridium Difficile Toxin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LLH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin TestLLH · Traditional | First Light Diagnostics, Inc. | 07/08/2021SE |
| K102242 | Osom C. Difficile Toxin A/B TestLLH · Traditional | Genzyme Corporation | 12/21/2010SE |
| K091109 | Xpert C. DifficileLLH · Traditional | Cepheid | 07/09/2009SE |
| K090239 | Progastro CD AssayLLH · Traditional | Prodesse, Inc. | 04/16/2009SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | Techlab, Inc. | 03/26/2009SE |
| K081920 | BD Geneohm Cdiff AssayLLH · Traditional | Bd Diagnostics (Geneohm Sciences, Inc.) | 12/19/2008SE |
| K080931 | Vidas C. Dificile Toxin a & B (Cdab) AssayLLH · Traditional | bioMerieux, Inc. | 06/11/2008SE |
| K072138 | Vidas C. Difficile Toxin A&B (Cdab) Assay, Model: 30 118LLH · Traditional | bioMerieux, Inc. | 12/21/2007SE |
| K050891 | Tox A/B Quick ChekLLH · Traditional | Techlab, Inc. | 07/25/2005SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | Remel, Inc. | 11/15/2004SE |
More from Remel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993914 | Premier Toxins A&B, Model 616096LLH · Special | 12/10/1999SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | 08/09/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | 06/25/1999SE |
| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | 06/25/1999SE |
| K983255 | Modification to: Premier Platinum HpsaLYR · Traditional | 12/17/1998SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | 12/03/1998SE |
| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Premier C. Difficile, Modification cleared by the FDA?
Premier C. Difficile, Modification (K926442) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 42 days after the submission was received.
What is the product code of K926442?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.