Osom C. Difficile Toxin A/B Test
FDA 510(k) K102242 · Genzyme Corporation
510(k) numberK102242
Submission
- Device name
- Osom C. Difficile Toxin A/B Test
- Applicant
- Genzyme Corporation
Framingham, MA, US - Received
- August 9, 2010
- Decision date
- December 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| K193490 | SensiTox C. difficile Toxin TestLLH · Traditional | First Light Diagnostics, Inc. | 07/08/2021SE |
| 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 |
| K041003 | Immunocard Toxins a & B, Model 712050LLH · Traditional | Meridian Bioscience, Inc. | 08/20/2004SE |
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| K063739 | Sepramesh, Model 5959-1214FTL · Traditional | 01/17/2007SE |
| K061508 | Osom Influenza A&B TestPSZ · Traditional | 06/12/2006SE |
| K051244 | Genzyme Osom Influenza a & B TestPSZ · Traditional | 02/21/2006SE |
| K053066 | Sepramesh Ip Bioresorbable Coating/Permanent MeshFTL · Traditional | 12/19/2005SE |
| K043035 | Sepragel ENT Bioresorbable Packing/StentKHJ · Traditional | 07/11/2005SE |
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| K040868 | Sepramesh Ip Bioresorbable Barrier - Permanent MeshFTM · Traditional | 06/04/2004SE |
| K033864 | Genzyme Osom Trichomonas Rapid TestJWZ · Traditional | 04/02/2004SE |
Questions and answers
When was Osom C. Difficile Toxin A/B Test cleared by the FDA?
Osom C. Difficile Toxin A/B Test (K102242) received a 510(k) decision of Substantially Equivalent on December 21, 2010, 134 days after the submission was received.
What is the product code of K102242?
The FDA product code is LLH – Reagents, Clostridium Difficile Toxin, a Class I (low risk) device regulated under 21 CFR 866.2660.