TOX A/B TEST
FDA 510(k) clearance K971182 · decided 1997-07-22
Clearance details
- K-number
- K971182
- Device name
- TOX A/B TEST
- Applicant
- Techlab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-31
- Decision date
- 1997-07-22
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- LLH
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Blacksburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SensiTox C. difficile Toxin Test (K193490) | First Light Diagnostics, Inc. | 2021-07-08 |
| OSOM C. DIFFICILE TOXIN A/B TEST (K102242) | Genzyme Corporation | 2010-12-21 |
| XPERT C. DIFFICILE (K091109) | Cepheid | 2009-07-09 |
| PROGASTRO CD ASSAY (K090239) | Prodesse, Inc. | 2009-04-16 |
| C. DIFF QUIK CHEK COMPLETE (K082499) | Techlab, Inc. | 2009-03-26 |
| BD GENEOHM CDIFF ASSAY (K081920) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |
| VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (K080931) | bioMerieux, Inc. | 2008-06-11 |
| VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (K072138) | bioMerieux, Inc. | 2007-12-21 |
| TOX A/B QUICK CHEK (K050891) | Techlab, Inc. | 2005-07-25 |
| XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (K041951) | Remel, Inc. | 2004-11-15 |
| IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003) | Meridian Bioscience, Inc. | 2004-08-20 |
| C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 (K032897) | Ivd Research, Inc. | 2004-05-27 |
Recalls involving this device
No recalls on record reference this clearance.