510(k) K053572
- Device
- C. DIFF QUIK CHEK
- Applicant
- TECHLAB, INC.
- 510(k) number
- K053572
- Product code
- MCB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-26
- Date received
- 2005-12-22
- Regulation
- 866.2660
- Classification name
- Antigen, C. Difficile
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID M LYERLY
- Address
- 2001 Kraft Dr. Blacksburg VA US 24060 24060
FDA Registration Numbers#
- 3004569406
- 9615056
- 2182595
- 1524213
- 3009935129
- 1122855
- 1528450
- 8020790
Source Documents#
Other 510(k) Records For Product Code MCB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132010 | VIDAS C DIFFICILE GDH | Biomerieux S.A. | 2013-10-09 |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-12-16 |
| K110620 | PREMIER C. DIFFICILE GDH | Meridian Bioscience, Inc. | 2011-05-03 |
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | Biosite Incorporated | 1998-03-20 |
| K955067 | CLEARVIEW C. DIFF A | Unipath , Ltd. | 1996-09-13 |
| K924062 | MERITEC C. DIFFICILE CONTROLS | Meridian Diagnostics, Inc. | 1992-10-19 |
| K904329 | CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1991-03-12 |
| K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | Meridian Diagnostics, Inc. | 1990-03-12 |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | Bartels Immunodiagnostic Supplies, Inc. | 1984-05-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary