Cytotoxicity Assay for Clostridium-
FDA 510(k) K833447 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK833447
Submission
- Device name
- Cytotoxicity Assay for Clostridium-
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Walker, MI, US - Received
- October 5, 1983
- Decision date
- May 21, 1984
- 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 |
| K904329 | Clostridium Difficile Toxin a Enzyme ImmunoassayMCB · Traditional | Baxter Healthcare Corp | 03/12/1991SE |
| K895915 | Meritec(Tm) - C. Difficile Latex Test SystemMCB · Traditional | Meridian Diagnostics, Inc. | 03/12/1990SE |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864776 | A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional | 12/31/1986SE |
| K861172 | Rotavirus Latex Agglutination AssayLIQ · Traditional | 07/01/1986SE |
| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | 05/13/1986SE |
| K855034 | American Histo-Id Sys Primary Kit Psa Prostate AntLIJ · Traditional | 03/11/1986SE |
| K842830 | Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional | 11/26/1985SE |
| K852185 | Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional | 08/19/1985SE |
| K844105 | Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional | 12/06/1984SE |
| K842834 | HEP-2 CellsKJR · Traditional | 08/28/1984SE |
| K842833 | PMK Primary Monkey Kidney-CellsKJR · Traditional | 08/28/1984SE |
| K842328 | Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional | 08/03/1984SE |
Questions and answers
When was Cytotoxicity Assay for Clostridium- cleared by the FDA?
Cytotoxicity Assay for Clostridium- (K833447) received a 510(k) decision of Substantially Equivalent on May 21, 1984, 229 days after the submission was received.
What is the product code of K833447?
The FDA product code is MCB – Antigen, C. Difficile, a Class I (low risk) device regulated under 21 CFR 866.2660.