Clostridium Difficile Toxin a Enzyme Immunoassay
FDA 510(k) K904329 · Baxter Healthcare Corp
510(k) numberK904329
Submission
- Device name
- Clostridium Difficile Toxin a Enzyme Immunoassay
- Applicant
- Baxter Healthcare Corp
Bellevue, WA, US - Received
- September 20, 1990
- Decision date
- March 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MCB – Antigen, C. Difficile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code MCB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132010 | Vidas C Difficile GDHMCB · Traditional | Biomerieux S.A. | 10/09/2013SE |
| K112048 | Immunocard C. Difficile GDHMCB · Traditional | Meridian Bioscience, Inc. | 12/16/2011SE |
| K110620 | Premier C. Difficile GDHMCB · Traditional | Meridian Bioscience, Inc. | 05/03/2011SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | Techlab, Inc. | 04/26/2006SE |
| K974881 | Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aMCB · Traditional | Biosite Incorporated | 03/20/1998SE |
| K955067 | Clearview C. Diff aMCB · Traditional | Unipath , Ltd. | 09/13/1996SE |
| K924062 | Meritec C. Difficile ControlsMCB · Traditional | Meridian Diagnostics, Inc. | 10/19/1992SE |
| K895915 | Meritec(Tm) - C. Difficile Latex Test SystemMCB · Traditional | Meridian Diagnostics, Inc. | 03/12/1990SE |
| K833447 | Cytotoxicity Assay for Clostridium-MCB · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 05/21/1984SE |
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Questions and answers
When was Clostridium Difficile Toxin a Enzyme Immunoassay cleared by the FDA?
Clostridium Difficile Toxin a Enzyme Immunoassay (K904329) received a 510(k) decision of Substantially Equivalent on March 12, 1991, 173 days after the submission was received.
What is the product code of K904329?
The FDA product code is MCB – Antigen, C. Difficile, a Class I (low risk) device regulated under 21 CFR 866.2660.